These companies market shoulder replacement systems in the US. Most shoulder implants reach the market through FDA 510(k) clearance, meaning they were judged substantially equivalent to existing devices, not proven better. Listed alphabetically. No company pays to be listed. Product lines change often, so confirm current details in the FDA 510(k) database.
The 2026 AAOS Shoulder & Elbow Registry report found reverse replacements made up 52.7% of 39,251 shoulder replacements, versus 35.1% anatomic. (AAOS.)
Listing a company or product is not an endorsement, and no company pays to be listed. This list may be incomplete. Compiled November 2026 from FDA records, company pages and trade press.
Advita Ortho (formerly Exactech)
Equinoxe Shoulder System
- Options
- Anatomic, reverse and stemless anatomic.
- Planning
- Equinoxe planning software and ExactechGPS navigation.
- US status
- Equinoxe Shoulder System 510(k) cleared April 2026.
- Recent changes
- Exactech's assets were sold in its restructuring, and Advita Ortho launched with them in November 2025. Advita received an FDA warning letter in December 2025 related to the Equinoxe Reverse Shoulder System.
Sources: FDA K260583 (PDF) · Advita launch
Arthrex
Univers Revers Total Shoulder System
- Options
- Reverse, with a 135° design and augmented glenoid baseplates.
- US status
- FDA 510(k) cleared; multiple clearances since 2014.
Sources: Product page
Catalyst OrthoScience
Catalyst shoulder systems
- Options
- Anatomic and fracture systems; the fracture system was cleared for anatomic shoulder indications in December 2025 and can convert to reverse.
- Planning
- Archer patient-specific instrumentation, FDA cleared.
Sources: Business Wire
DePuy Synthes (J&J MedTech)
INHANCE Shoulder System
- Options
- Anatomic and reverse, with a stemless-first design that can switch to a stemmed implant during the same operation.
- Planning
- TRUMATCH personalized planning.
Sources: J&J INHANCE page · Shoulder products
Enovis
AltiVate shoulder system; SMR and PRIMA (from LimaCorporate)
- Options
- Anatomic and reverse (AltiVate), plus Lima's SMR modular system and PRIMA after Enovis bought LimaCorporate in January 2024.
- US status
- AltiVate Reverse, RSP, SMR and PRIMA systems on a 510(k) cleared May 2025.
Sources: FDA K251184 · Lima deal
FX Shoulder Solutions
FX V135 Easytech Shoulder System
- Options
- Stemless shoulder implant.
- US status
- 510(k) cleared May 2026.
Sources: Ryortho
restor3d
Reverse Total Shoulder Arthroplasty System
- Options
- Reverse, for primary, fracture or revision; porous humeral components for cemented or uncemented use.
- US status
- 510(k) cleared May 2025.
Sources: FDA K243643
Shoulder Innovations
InSet anatomic and reverse systems
- Options
- Anatomic and reverse systems built on an inset glenoid design.
- Planning
- ProVoyance CT-based planning software.
- Company
- Shoulder-only company, public on the NYSE since July 2025.
Sources: FDA glenosphere clearance K252516 · IPO coverage
Smith+Nephew
AETOS Shoulder System
- Options
- Anatomic total shoulder system; a stemless anatomic option was cleared in January 2025.
Sources: Healio
Stryker
Tornier shoulder portfolio (Perform)
- Options
- Anatomic and reverse (Tornier Perform humeral and glenoid components).
- Planning or robotics
- Blueprint 3D planning; Mako Shoulder robotic system for primary reverse replacement, in full US release since early 2026.
Sources: Mako Shoulder · MassDevice
Zimmer Biomet
Identity, Comprehensive and OsseoFit shoulder systems
- Options
- Identity (anatomic, reverse, revision and fracture with one instrument set, cleared April 2026), Comprehensive Reverse, and OsseoFit stemless (cleared December 2024).
- Robotics
- ROSA Shoulder; an updated version for anatomic and reverse cases was cleared May 2026.
Sources: Identity clearance · ROSA Shoulder
