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510(k) K253515

Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments by Biomet Orthopedics, Inc. — Product Code JDI

K253515 is an FDA 510(k) premarket notification submitted by Biomet Orthopedics, Inc. for the device "Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments". The FDA issued a decision of Substantially Equivalent on August 24, 2026. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Biomet Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2026
Date Received
November 7, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Biomet Orthopedics, Inc.

  • K252404 — Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (April 15, 2026)
  • K243761 — A.L.P.S. Small Fragment Plating System (February 19, 2025)
  • K223631 — Comprehensive Segmental Revision System(SRS) (July 12, 2023)
  • K200196 — Taperloc® Complete Hip Stems (December 8, 2020)
  • K131393 — MAK OSS FEMORAL KNEE COMPONENTS (October 24, 2013)
  • K112905 — COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM (May 24, 2012)
  • K080528 — E-POLY TIBIAL BEARINGS (June 17, 2008)
  • K072879 — INNERVUE DIAGNOSTIC SCOPE SYSTEM (January 14, 2008)
  • K070955 — ACID ETCHED LAG SCREWS (October 12, 2007)
  • K033355 — LACTOSCREW SCREW ANCHOR (June 30, 2004)

Other clearances for product code JDI

  • K253434 — OSSTM Orthopedic Salvage System (July 1, 2026)
  • K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (March 12, 2026)
  • K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained L (July 31, 2025)
  • K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr (October 21, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)

FDA data resources