Cleared Traditional

K951232 - EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM

K951232 is an FDA 510(k) clearance for EXPANDED RANGE OF SUTURE SIZES OGDEN AN..., manufactured by American Medical Electronics, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K951232 · American Medical Electronics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
158d
Days
Class 2
Risk

K951232 is an FDA 510(k) clearance for the EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by American Medical Electronics, Inc. (Richardson, US). The FDA issued a Cleared decision on August 25, 1995 after a review of 158 days - an extended review cycle.

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 American Medical Electronics, Inc. devices

FDA 510(k) Submission Details - K951232

510(k) Number K951232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1995
Decision Date August 25, 1995
Days to Decision 158 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 122d · This submission: 158d
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 1013
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K951232.
STRYKER ACL INTERFERENCE SCREW SYSTEM
K952460 · Stryker Endoscopy · Sep 1995
BIOSCREW ABSORBABLE INTERFERENCE SCREW
K952831 · Linvatec Corp. · Sep 1995
TITANIUM CLASSIC COMPRESSION HIP SCREW SYSTEM
K952697 · Smith & Nephew Richards, Inc. · Sep 1995
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
K952296 · Synthes (Usa) · Aug 1995
TI. ALLOY 2.0 MM CORTEX SCREW
K952272 · Synthes (Usa) · Jul 1995
REUNION BONE SCREW SYSTEM
K951389 · Smith & Nephew Richards, Inc. · Jul 1995