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Sign in to claim this brandARTHROSURFACE INCORPORATED
US
Last updated May 24, 2026
What ARTHROSURFACE INCORPORATED makes
ArthroSurface Incorporated manufactures orthopaedic joint prostheses, including partial-resurfacing knee and shoulder replacements, unicondylar knee implants, and metatarsophalangeal joint prostheses. Their portfolio also includes internal orthopaedic fixation systems such as non-bioabsorbable plates and screws, as well as bone screws for specific joint applications, such as the carpal lunate. These devices are designed for partial joint resurfacing and fracture fixation in orthopaedic surgery.
The company’s devices are regulated under FDA’s classification system, with products falling into Class I, Class II, and Unclassified (U) categories. These implants are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does ArthroSurface Incorporated manufacture?
ArthroSurface Incorporated specializes in orthopaedic joint prostheses and fixation systems. Their product portfolio includes partial-resurfacing knee and shoulder implants (such as the HemiCAP® and UniCAP®), unicondylar knee prostheses, metatarsophalangeal joint replacements (e.g., ToeMATE®), and internal orthopaedic fixation systems like non-bioabsorbable plates and screws. These devices are designed for partial joint resurfacing and fracture stabilization in orthopaedic surgery.
Where is ArthroSurface Incorporated based?
The company is headquartered in the United States. While the exact location isn’t specified, its operations are based within the country, where it develops and manufactures its orthopaedic devices.
Which regulatory registries or databases list ArthroSurface Incorporated’s devices?
ArthroSurface Incorporated’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations by assigning a standardized identifier to each product.
How are ArthroSurface Incorporated’s devices classified under FDA regulations?
The company’s devices fall into different FDA classification categories depending on their intended use and risk level. Some are classified as Class I (low-risk, general controls), others as Class II (moderate-risk, requiring special controls), and a few remain Unclassified (U) pending further regulatory determination. Classification determines the regulatory pathway for authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- arthrosurface.com
- —
- —
- [email protected]
- Phone
- 508-520-3003
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 144666109
Catalogue (425)
Page 1 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HemiCAP® | 8135-0032-W | FDA UDI | Class II | Active |
| UniCAP® | U202-0831-W | FDA UDI | Class II | Active |
| ToeMATE® | 9H00-T050 | FDA UDI | Class II | Active |
| HemiCAP® | P202-3035-W | FDA UDI | Class II | Active |
| BOSS Toe Fixation System | 9CRS-D100-A | FDA UDI | Class II | Active |
| WaveKahuna™ | PWL2-1005-W | FDA UDI | Class II | Active |
| CheckMate® | 4F01-4024 | FDA UDI | Class II | Active |
| AlignMate | 9B01-5046-A | FDA UDI | Class II | Active |
| HemiCAP® | P202-3525-W | FDA UDI | Class II | Active |
| UniCAP® | U202-0821-W | FDA UDI | Class II | Active |
| UniCAP® | U202-1035-A | FDA UDI | Class II | Active |
| UniCAP® | US02-3010-W | FDA UDI | Class II | Active |
| HemiCAPGRS® | G203-2520-W | FDA UDI | Class II | Active |
| HemiCAP® | P206-0040-W | FDA UDI | Class II | Active |
| HemiCAP® | 8402-1010-W | FDA UDI | Class II | Active |
| HemiCAPWAVE® | PX75-0173-W | FDA UDI | Class II | Active |
| HemiCAP® | 9152-1525-W | FDA UDI | Class II | Active |
| HemiCAP® | 9152-2040-A | FDA UDI | Class II | Active |
| HemiCAP® | 9152-1535-A | FDA UDI | Class II | Active |
| UniCAP® | US02-3510-W | FDA UDI | Class II | Active |
| CheckMate® | 4F01-1014 | FDA UDI | Class II | Active |
| HemiCAPWAVE® | P255-1050-W | FDA UDI | Class II | Active |
| HemiCAP® | P202-2025-W | FDA UDI | Class II | Active |
| CheckMate® | 4F01-4030 | FDA UDI | Class II | Active |
| HemiCAPITATETM | 8W15-2223-A | FDA UDI | Class II | Active |
| HemiCAPGRS® | G007-1400 | FDA UDI | Class II | Active |
| HemiCAP® | 8402-9090-W | FDA UDI | Class II | Active |
| RevoMotion | 8RS4-1025 | FDA UDI | Class II | Active |
| WristMotion® Wrist Hemiarthroplasty System | 8W12-3517-W | FDA UDI | Class II | Active |
| Arthrosurface Bone Screw | 9A2D-B014 | FDA UDI | Class II | Active |
| UniCAP® | U000-0100 | FDA UDI | Class II | Active |
| HemiCAP® | H352-0065-W | FDA UDI | Class II | Active |
| UniCAP® | U202-0935-W | FDA UDI | Class II | Active |
| OVOMotion™ | 8HM2-4844-A | FDA UDI | Class II | Active |
| HemiCAP® | 9122-1020-A | FDA UDI | Class II | Active |
| UniCAP® | US02-3520-W | FDA UDI | Class II | Active |
| WristMotion® Wrist Hemiarthroplasty System | 8W15-2217-W | FDA UDI | Class II | Active |
| ToeMATE® | 9H00-T020 | FDA UDI | Class II | Active |
| HemiCAP® | P202-2020-W | FDA UDI | Class II | Active |
| HemiCAP® | 8252-0050-A | FDA UDI | Class II | Active |
| UniCAP® | U202-0731-W | FDA UDI | Class II | Active |
| HemiCAP® | 8352-7070-W | FDA UDI | Class II | Active |
| HemiCAP® | 9122-1020-W | FDA UDI | Class II | Active |
| AlignMate | 9B09-2000 | FDA UDI | Class I | Active |
| OVOMotion™ | 8HM2-5854-A | FDA UDI | Class II | Active |
| WaveKahuna™ | PWL2-1155-W | FDA UDI | Class II | Active |
| RevoMotion | 8RS4-1020 | FDA UDI | Class II | Active |
| OsteoMate | 9K00-0100 | FDA UDI | Class I | Active |
| Pinit Plate® | 9A2A-B018 | FDA UDI | Class II | Active |
| HemiCAPOVO® | 8H02-5046-A | FDA UDI | Class II | Active |
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