510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K071569Substantially Equivalent

Allthread Peek Anchor with Tantalum Marker

Zimmer GmbH, Warsaw IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071569 is the FDA 510(k) clearance record for ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER, a class II device, cleared for Biomet, Inc. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K071569.

Clearance record

Decision date
Received
(24 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. 56 E. Bell Dr., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBI

Trailing 12 months
32 clearances under product code MBI in the twelve months to November 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20262
November 20260