Cleared Traditional

K011102 - ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM

K011102 is an FDA 510(k) clearance for ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRU..., manufactured by Aesculap, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K011102 · Aesculap, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
114d
Days
Class 2
Risk

K011102 is an FDA 510(k) clearance for the ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on August 3, 2001 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Aesculap, Inc. devices

FDA 510(k) Submission Details - K011102

510(k) Number K011102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2001
Decision Date August 03, 2001
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 122d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 980
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K011102.
INTEX SCREW
K012798 · Biomet, Inc. · Nov 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821 · New Deal, S.A. · Sep 2001
THE SPIN SNAP-OFF SCREW
K011946 · New Deal, S.A. · Aug 2001
IN-FAST BONE SCREW SYSTEM
K011910 · American Medical Systems, Inc. · Jul 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · Osteomed Corp. · Jul 2001
PLUS CANCELLOUS BONE SCREWS
K011719 · Plus Orthopedics · Jul 2001