Product code JDI: 510(k) clearances and predicates
Product code JDI covers Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments. FDA lists 565 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
565 clearances on file under product code JDI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 so far | 3 |
Recent clearances
Newest JDI clearances in the FDA index, with applicant and decision date:
- K253515, Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments, applicant Biomet Orthopedics, Inc., decided 2026-08-24. FDA record
- K253434, OSSTM Orthopedic Salvage System, applicant Biomet, Inc., decided 2026-07-01. FDA record
- K252824, Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head, applicant Signature Orthopaedics Pty, Ltd., decided 2026-03-12. FDA record
- K243571, Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners, applicant Zimmer Biomet, decided 2025-07-31. FDA record
- K240783, Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems, applicant Smith & Nephew, Inc., decided 2024-10-21. FDA record
- K241716, Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component, applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics, decided 2024-08-02. FDA record
- K240418, Stryker Orthopaedics Hip Systems Labeling Update, applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics, decided 2024-04-12. FDA record
- K233261, Global Modular Replacement System, applicant Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, decided 2023-12-08. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include OSSTM Orthopedic Salvage System, Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head. Watch new JDI clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JDI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JDI clearances include Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments.
How many 510(k) clearances use product code JDI?
565 at the time this page was generated, from openFDA records.
How do I find a predicate device under JDI?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JDI clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.