TEMPERLITE(TM) SAW BLADE— 510(k) K911902

Clearance details

Applicant

Sierra Surgical, Inc.

Product code

Code HSD

Device class

Class 2

Regulation

21 CFR 888.3690

Advisory panel

Orthopedic

Date received

1991-04-26

Decision date

1991-06-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Rancho Cordova, CA, US

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• K191433 — AGILON® XO Shoulder Replacement System2020-11-12
• K193122 — Biocore9 Humeral Resurfacing System2020-05-15
• K173964 — OVOMotion Shoulder Arthroplasty System2018-04-18

Injury

3,425

Malfunction

531

Total

3,956

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1127-2013 — The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.Class II·Terminated·Synvasive Technology Inc·20130314

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K911902.