510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K011102Substantially Equivalent

Anterior Cruciate Ligament (Acl) Instrument System

Aesculap Inc, Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011102 is the FDA 510(k) clearance record for ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM, a class II device, cleared for Aesculap, Inc. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 269 510(k) clearances for Aesculap, Inc., from to . As of , FDA records show no recalls naming K011102.

Clearance record

Decision date
Received
(114 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Aesculap, Inc. 3773 Corporate Pkwy., Center Valley PA
510(k) summary
Summary
Third party review
No

Clearances, product code HWC

Trailing 12 months
22 clearances under product code HWC in the twelve months to November 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code HWC, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20262
April 20263
May 20264
June 20262
July 20261
August 20263
September 20264
October 20262
November 20260