510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K980595Substantially Equivalent

Depuy Orthotech Catera Suture Anchor

Depuy Orthopaedics Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980595 is the FDA 510(k) clearance record for DEPUY ORTHOTECH CATERA SUTURE ANCHOR, a class II device, cleared for DePuy Orthopaedics, Inc. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 209 510(k) clearances for DePuy Orthopaedics, Inc., from to . As of , FDA records show no recalls naming K980595.

Clearance record

Decision date
Received
(83 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
DePuy Orthopaedics, Inc. 700 Orthopaedic Dr., Warsaw IN
510(k) summary
Summary
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