# Arthrosurface, Inc. – FDA 483, Apr 1, 2026

Source: https://www.keypedia.com/records/483/arthrosurface-inc/7c2e9363-6531-4034-9789-99a725f8aef1

> FDA 483 for Arthrosurface, Inc. on April 01, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arthrosurface, Inc.
- Inspection Date: 2026-04-01
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Arthrosurface, Inc. in West Bridgewater, MA, revealed significant deficiencies in the documentation and validation of sterilization processes for their orthopedic implants. The firm failed to provide evidence of required reviews for dose audits and lacked documented rationale for changes in bioburden limit formulas. Additionally, the recommended sterilization time for reusable instrument sets had not been validated.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/arthrosurface-inc/4d18e49d-3a81-498f-a2cf-63d66c4907f5

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144