Reading as
Plain-language core. Switch lenses to reveal technical or purchasing detail.
All topics
  1. What it is
  2. Who it helps
  3. Timing
  4. The procedure
  5. Patient journey
  6. Recovery supplies
  7. Implant designs
  8. Side-by-side
  9. Robotics and alignment
  10. US manufacturers
  11. What the evidence says
  12. Value analysis
  13. Questions to ask
  14. Resources
  15. Glossary
  16. References

US market

Knee implant manufacturers in the United States

These companies market total knee replacement systems in the US. Most knee implants reach the market through FDA 510(k) clearance as Class II devices, which is why you'll usually see "FDA cleared" rather than "FDA approved."

Listed alphabetically. Compiled October 2026 from company pages, FDA records and press releases linked on each card. No company pays to be listed. This list may not be complete and product lines change, so confirm current status in the FDA 510(k) database.

Corin

Unity Knee

Fixation and materials
Cobalt-chrome femur; vitamin E cross-linked polyethylene
Design
Medial-congruent (MC) and posterior-stabilized (PS-C) inserts
Robotics or navigation
Apollo robotic platform with ApolloKnee, FDA cleared for TKA (announced November 2023)
US status
Unity Knee MC insert 510(k) cleared, announced October 2024, in a US limited market release; PS-C insert cleared June 2024 (K240875)
Company websiteClearance source

Enovis (DJO Surgical)

EMPOWR Knee (3D, CR, Porous, Complex Primary)

Fixation and materials
Includes a porous option for cementless fixation
Design
Described by the company as "dual-pivot" kinematics
Robotics or navigation
ARVIS augmented-reality guidance (not a robot)
US status
Marketed on the company's US surgical site
Product page

Exactech

Truliant Knee System

Fixation and materials
3D-printed porous tibial tray option (reported October 2024)
Design
CR and PS options; Newton gap-balancing technology
Robotics or navigation
ExactechGPS computer navigation (not a robot)
US status
Knee product lines transferred to new owners in a court-approved 2025 sale; earlier Optetrak, Logic and Truliant inserts were part of a 2021 to 2022 packaging recall (see below). Confirm current US distribution with the company.
Company website

Globus Medical

ACTIFY and ACTIFY 3D Total Knee

Fixation and materials
ACTIFY 3D is 3D printed with a porous lattice for cemented or cementless use
Design
CR, ultra-congruent and PS inserts
Robotics or navigation
ExcelsiusFlex robotic system, 510(k) cleared for TKA with ACTIFY 3D (announced July 2024)
US status
Cleared and marketed in the US
Product pageClearance source

J&J MedTech (DePuy Synthes)

ATTUNE Knee System

Fixation and materials
Cemented and cementless (porous-coated) options, fixed and rotating-platform bearings
Design
Includes a medial-stabilized fixed-bearing insert (cleared August 2021)
Robotics or navigation
VELYS Robotic-Assisted Solution, 510(k) cleared for use with ATTUNE (announced January 2021)
US status
Marketed on the company's US site. J&J has announced plans to separate its orthopaedics business as DePuy Synthes, targeting mid-2027.
Product page

LINK (LinkBio)

GEMINI SL Total Knee System

Fixation and materials
Cemented; PorEx surface treatment
Design
Fixed-bearing CR and PS, and mobile-bearing options
Robotics or navigation
None found
US status
Listed on the company's US site, which notes availability varies by location
Product page

Maxx Orthopedics

Freedom Total Knee System

Fixation and materials
Porous knee option; TiNbN-coated Titan option
Design
Medial-congruent, ultracongruent, CR and PS inserts; designed for high flexion
Robotics or navigation
Reported compatibility with THINK Surgical's TMINI robot
US status
Freedom Knee originally cleared 2009 (K082019); Titan stemmed components cleared July 2024 (K240863)
Product page

Medacta

GMK Total Knee System (GMK Sphere, GMK SpheriKA)

Fixation and materials
Cementless femoral option cleared January 2023 (K223548)
Design
GMK Sphere has a medial "ball-in-socket" design; SpheriKA is designed for kinematic alignment; MyKnee patient-matched guides
Robotics or navigation
NextAR augmented reality; THINK Surgical TMINI cleared for use with GMK Sphere and SpheriKA (reported August 2024)
US status
510(k) cleared
Product page

MicroPort Orthopedics

Evolution Medial-Pivot Knee System

Fixation and materials
Cemented
Design
Medial-pivot design; Prophecy patient-specific guides
Robotics or navigation
Pixee Medical Knee+ augmented reality (announced November 2022)
US status
US-based company; product availability varies by country
Product page

Ortho Development

Balanced Knee System (BKS, BKS TriMax)

Fixation and materials
Vitamin E cross-linked polyethylene
Design
CR, ultracongruent, PS and PS Plus inserts; MRI-based patient-specific guides
Robotics or navigation
Cleared for use with THINK Surgical's TSolution One (announced May 2021)
US status
Marketed on the company's US site
Product page

restor3d (Conformis)

iTotal Identity, Identity Imprint

Fixation and materials
Cementless 3D-printed porous version (iTotal Identity CR 3DP Porous) cleared, announced April 2025
Design
Implants designed from each patient's CT scan, with personalized single-use instruments
Robotics or navigation
None; uses patient-specific instrumentation
US status
Marketed on the company's US site; restor3d acquired Conformis in 2023
Product pageClearance source

Smith+Nephew

JOURNEY II TKA, LEGION, LANDMARK

Fixation and materials
OXINIUM oxidized zirconium option; LANDMARK has a 3D-printed femoral component
Design
JOURNEY II is an anatomic design with an asymmetric shape
Robotics or navigation
CORI handheld robotics, available in the US for total and partial knees since July 2020
US status
JOURNEY II on the company's US site; LANDMARK 510(k) cleared September 2026 (K261462) with a phased launch
Product pageLANDMARK clearance

Stryker

Triathlon Total Knee System

Fixation and materials
Cementless option with a 3D-printed porous titanium baseplate (Triathlon Tritanium)
Design
Single-radius femoral design; CR, condylar-stabilizing and PS options
Robotics or navigation
Mako robotic-arm, FDA cleared for TKA (announced August 2015)
US status
Marketed on the company's US site
Product page

Total Joint Orthopedics

Klassic Knee System

Fixation and materials
Cementless option; vitamin E polyethylene; titanium-nitride-coated option
Design
Universal (non-sided) femoral component; CR through PS inserts
Robotics or navigation
None found
US status
Marketed on the company's US site
Product page

United Orthopedic (UOC USA)

U2 Total Knee System

Fixation and materials
Cemented
Design
Semi-constrained system with stem extensions
Robotics or navigation
None found
US status
Original 510(k) K082424; stem extensions cleared September 2025 (K252725)
Product page

Zimmer Biomet

Persona, NexGen, Vanguard

Fixation and materials
Cementless option (Persona OsseoTi 3D-printed porous titanium keel tibia, announced November 2022)
Design
Persona IQ includes an implanted sensor that records gait data (FDA De Novo, August 2021)
Robotics or navigation
ROSA Knee robotic system, cleared for TKA (January 2019); acquired Monogram's CT-based robot in October 2025
US status
Marketed on the company's US site
Product page

Recent changes and recalls

  • Exactech packaging recall. Polyethylene inserts for the Optetrak, Logic and Truliant knees made from 2004 to August 2021 were recalled because packaging lacked an oxygen barrier, which can increase wear. FDA safety communication. If you have an Exactech knee, ask your surgeon whether it's affected.
  • Zimmer NexGen recall. A size 7 NexGen Option stemmed tibial component was recalled in December 2022 over higher revision rates with certain femoral components. FDA recall record.
  • Aesculap stopped selling its knee replacement devices in the US as of April 2024, according to a Department of Justice release.
  • Ownership changes: restor3d acquired Conformis (2023), Enovis acquired LimaCorporate (2024), and Zimmer Biomet acquired Monogram Technologies (2025).
Value analysis

When comparing vendors, ask each for 510(k) numbers and cleared indications, registry survivorship data for the specific construct (not just the brand), robotic platform terms and disposables, set and tray counts, and pricing for cemented versus cementless and standard versus patient-specific options.