OOG
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Knee Arthroplasty Implantation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Medical specialty
- Orthopedic
- FDA definition
- Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
- Adverse events (MAUDE)
- 2019: 15 · 2022: 18 · 2023: 23 · 2024: 72 · 2025: 34 · 2026: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| United Orthopedic Knee Patient Specific Instrumentation (K230850) | Enhatch, Inc. | 2023-12-20 |
| Triathlon AS-1 (K203421) | Conformis, Inc. | 2021-04-19 |
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Every clearance here is in the API, with alerts when new ones post.