Kleiner Device Labs
Kleiner Device Labs develops single-use spinal fusion implants and graft delivery instruments for spine surgery. Its FDA-cleared KG2 Surge Flow-Thru Interbody System integrates a 3D-printed titanium implant with patented bone-graft delivery, targeting hospitals and ambulatory surgery centers.
- Company typePrivate
- Founded2013
- HeadquartersIncline Village, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Kleiner Device Labs does
Kleiner Device Labs (legal entity Spinal Surgical Strategies, Inc.) is a privately held medical device company founded in 2013 by spinal surgeon Dr. Jeff Kleiner and headquartered in Incline Village, Nevada. The company develops single-use instruments and implants designed to improve the process of minimally invasive and open spinal fusion surgery, with a primary focus on addressing inadequate bone graft delivery and distribution — a failure point historically associated with a 1-in-4 fusion failure rate and revision costs exceeding $135,000.
Its flagship product is the KG2 Surge Flow-Thru Interbody System, an FDA 510(k)-cleared, 3D-printed titanium I-beam interbody fusion implant with integrated, patented flow-thru bone-graft delivery technology. The device combines implant positioning and graft distribution into a single surgical pass, delivering an average of 10ml of graft per disc space in approximately 8 minutes of total elapsed time and achieving a graft-delivery cross-section 400% larger than conventional 4mm end-dispensing funnels. The previous-generation KG1 bi-directional graft delivery cannula is no longer commercially available, and the company is developing a KG3 expandable titanium implant targeted for 2026. Technology is protected by 23 U.S. patents (32 worldwide). The company sells directly to hospitals and ambulatory surgery centers (ASCs), supplemented by independent sales representatives and distributor partners, primarily in the United States and the United Kingdom.
Kleiner Device Labs firmographics
Firmographics- Name
- Kleiner Device Labs
- Legal name
- Spinal Surgical Strategies, Inc.
- Website
- https://kleinerlabs.com
- Company type
- Private
- Founded year
- 2013
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Kleiner Device Labs develops single-use spinal fusion implants and graft delivery instruments for spine surgery. Its FDA-cleared KG2 Surge Flow-Thru Interbody System integrates a 3D-printed titanium implant with patented bone-graft delivery, targeting hospitals and ambulatory surgery centers.
- Ownership category
- akta.pro rank
Kleiner Device Labs industry classification
Industry- Product category
- Spinal Surgical Implants
- NAICS
- Surgical Appliance and Supplies Manufacturing (339113), Surgical and Medical Instrument Manufacturing (339112)
- SIC
- Orthopedic, Prosthetic & Surgical Appliances & Supplies (3842), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Spine Implants & Motion Preservation (Fusion/Disc/Interspinous) (HLAHAEAC)
- akta.pro secondary industry
- 3D-Printed & Patient-Specific Implants (Custom Ortho/Spine/Cranial) (HLAHAEAJ)
Keywords
Where Kleiner Device Labs is headquartered
LocationHeadquarters
- HQ city
- Incline Village
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Kleiner Device Labs business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Supply Chain, Technology or R&D, Marketing or Sales, Operations, Others
Revenue model
- Medical Device Sales - Spinal Implants: Sale of proprietary spinal surgical devices (KG1 and KG2 Surge interbody systems) to hospitals, ASCs, and surgeons. Products are single-use, sterile implants delivered via direct sales and distributor networks.
Go-to-market motion2 records
Distribution channels3 records
Marketing channels7 records
Kleiner Device Labs product offering
Product offeringCore offering
Kleiner Device Labs develops and manufactures single-use spinal surgical implants and instruments for minimally invasive and open spinal fusion procedures. Its flagship product, the KG2 Surge Flow-Thru Interbody System, integrates a 3D-printed titanium I-beam fusion implant with a proprietary flow-thru graft delivery mechanism that combines implant positioning and bone graft distribution into a single surgical pass for PLIF and TLIF procedures. The company also previously marketed the KG1 bi-directional graft delivery cannula.
Product overview
Kleiner Device Labs offers a suite of spinal surgical implants and instruments designed to advance minimally invasive spine surgery. The company's product portfolio consists of two main product lines: the KG1 bi-directional graft delivery system (now discontinued) and the KG2 Surge flow-thru interbody system (current flagship product). Both products utilize proprietary flow-thru technology with dual exit portals to maximize bone graft delivery and distribution into the intervertebral disc space. The KG2 Surge represents an advancement over KG1 by combining the implant and graft delivery into a single integrated system. The company is also developing the KG3 expandable titanium implant (planned for 2026).
Differentiator
Problem solved
Functional benefit
Products and services
- KG2 Surge Flow-Thru Interbody System A single-patient-use bone graft delivery tool coupled with a 3D-printed titanium I-beam fusion implant that maximizes bone graft delivery to the intervertebral disc space for spine surgeons performing TLIF and PLIF procedures at hospitals and ambulatory surgery centers. FDA 510(k) cleared.
- KG1 Bi-Directional Graft Delivery System A disposable single-use bone graft delivery cannula with dual exit portals and a rectangular cross-section that delivers bone graft into the disc space. KG1 is no longer commercially available as a current offering.
Quantifiable outcome
- Increased spinal fusion success rates from 75% to 92% with KG1 device
- +7 more outcomes
Companies that use Kleiner Device Labs
Customer profileNamed customers7 records
Segments3 records
Ideal customer profiles2 records
Kleiner Device Labs technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature5 records
Kleiner Device Labs partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered minor.
- Southern Neurosurgical SocietyminorKDL presented e-Poster (#156) at Southern Neurosurgical Society's 2024 annual conference highlighting research on lumbar spinal implant and grafting technologies to reduce surgical risks.
- McKinsey & CompanyminorKDL hosted a meeting room at McKinsey & Company's Early Stage Investor Conference as part of the HealthTech track to meet prospective investors for future funding opportunities.
- North American Spine Society (NASS)minorKDL showcased the KG2 Surge at NASS Annual Meeting 2021 in Boston, demonstrating the system to surgeons and allograft suppliers with production-grade samples.
Scale indicators8 records
Recent moves6 records
Expansion highlights6 records
Kleiner Device Labs competitors and assessment
Company assessmentBroad incumbents
- Globus Medical: Large spine-focused medtech company with broad interbody fusion, MIS, and enabling technology portfolios. Most directly comparable incumbent to Kleiner's interbody fusion focus, though with vastly larger scale and product breadth.
- Orthofix Medical: Spine and orthopedic medtech incumbent offering interbody devices, biologics, and bone graft solutions. Comparable through its spine fusion and bone graft delivery product lines serving similar surgeon customers.
- Stryker (Spine division): Diversified medtech major with a spine division offering interbody fusion and MIS instrumentation. Competes for the same spine surgeon/hospital accounts but as part of a much broader device portfolio.
- Medtronic (Spine & Biologics): Largest spine medtech incumbent with market-leading interbody, biologics, and enabling technology portfolios. Sets the competitive benchmark Kleiner must displace in hospital accounts.
Direct peers
- NuVasive (now part of Globus Medical): Spine surgery specialist with extensive interbody fusion and MIS TLIF/PLIF portfolio. Highly comparable product overlap with Kleiner's KG2 Surge for lumbar interbody fusion procedures.
- Alphatec Holdings: Pure-play spine surgery company focused on TLIF/PLIF and lateral interbody fusion solutions. Closest size-stage comparable and most direct US-based peer in minimally invasive lumbar interbody fusion.
- SI-BONE: Spine-focused medtech specializing in minimally invasive sacropelvic solutions. Comparable as a spine-focused, single-platform medtech at similar growth stage; management overlap (former SI-BONE executives on Kleiner team).
- Xtant Medical: Spine-focused company offering interbody devices and biologics for spinal fusion. Comparable product adjacency and customer base (spine surgeons, hospitals/ASCs) at similar scale.
Emerging players
- Camber Spine: Emerging spine medtech developing novel interbody and MIS technologies. Comparable as a small, innovation-driven spine implant company targeting similar lumbar fusion indications.
- Aegis Spine: Niche spine implant company with interbody fusion products. Comparable through overlapping product categories and management-team lineage noted in Kleiner's leadership bios.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Kleiner Device Labs social profiles
Digital presenceKleiner Device Labs financial estimates
Financial estimateRevenue estimate
Valuation estimate
Kleiner Device Labs leadership team
Management profileNumber of profiles
Profiles11 records
Kleiner Device Labs funding detail
Funding detailFunding overview
Funding rounds6 records
Investors5 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Kleiner Device Labs M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Kleiner Device Labs
What does Kleiner Device Labs do?
Kleiner Device Labs develops and manufactures single-use spinal surgical implants and instruments for minimally invasive and open spinal fusion procedures. Its flagship product, the KG2 Surge Flow-Thru Interbody System, integrates a 3D-printed titanium I-beam fusion implant with a proprietary flow-thru graft delivery mechanism that combines implant positioning and bone graft distribution into a single surgical pass for PLIF and TLIF procedures. The company also previously marketed the KG1 bi-directional graft delivery cannula.
Is Kleiner Device Labs a public or private company?
Kleiner Device Labs is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Kleiner Device Labs founded?
Kleiner Device Labs was founded in 2013. It employs 11 to 50 people.
Where is Kleiner Device Labs based?
Kleiner Device Labs is headquartered in Incline Village, United States, in the North America region.
How does Kleiner Device Labs make money?
One revenue line is on record: medical Device Sales - Spinal Implants.
Who are Kleiner Device Labs's main competitors?
Broad incumbents on record are Globus Medical, Orthofix Medical, Stryker (Spine division) and Medtronic (Spine & Biologics). Direct peers are NuVasive (now part of Globus Medical), Alphatec Holdings, SI-BONE and Xtant Medical. Emerging players are Camber Spine and Aegis Spine.
Does Kleiner Device Labs have an API?
No public API is recorded for Kleiner Device Labs.
What industry is Kleiner Device Labs in?
Kleiner Device Labs's product category is Spinal Surgical Implants. Its primary akta.pro industry code is HLAHAEAC, Spine Implants & Motion Preservation (Fusion/Disc/Interspinous), with a secondary code of HLAHAEAJ, 3D-Printed & Patient-Specific Implants (Custom Ortho/Spine/Cranial). Its NAICS code is 339113 and its SIC code is 3842.