Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OSSTM Orthopedic Salvage System

K-Number: K253434 · 2026-07-01

ApplicantBiomet, Inc.
Decision Date2026-07-01
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSSTM Orthopedic Salvage System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K253434. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSTM Orthopedic Salvage System?

OSSTM Orthopedic Salvage System is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Biomet, Inc.. The 510(k) number is K253434.

When did OSSTM Orthopedic Salvage System receive FDA 510(k) clearance?

OSSTM Orthopedic Salvage System received FDA 510(k) clearance on 2026-07-01, under 510(k) number K253434.

Who is the listed applicant for OSSTM Orthopedic Salvage System?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSTM Orthopedic Salvage System?

The FDA product code for OSSTM Orthopedic Salvage System is JDI.

Other records listing Biomet, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer MoldsK212431Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

View all 36 devices →

Related Devices (Code: JDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK233261Global Modular Replacement SystemHowmedica Osteonics Corp. A.K.A. Stryker OrthopaedicsK222056Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeHowmedica Osteonics Corp., Dba Stryker Orthopaedics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑