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FDA 510(k)

Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments

K-Number: K253515 · 2026-08-24

ApplicantBiomet Orthopedics, Inc.
Decision Date2026-08-24
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2026-08-24 under 510(k) number K253515. 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 Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments?

Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments is a medical device that received FDA 510(k) clearance on 2026-08-24. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K253515.

When did Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments receive FDA 510(k) clearance?

Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments received FDA 510(k) clearance on 2026-08-24, under 510(k) number K253515.

Who is the listed applicant for Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments?

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

What is the FDA product code for Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments?

The FDA product code for Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and Augments is JDI.

Other records listing Biomet Orthopedics, Inc. as applicant

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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.

K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.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 Orthopaedics

Official Source

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

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