Cleared Traditional

K952272 - TI. ALLOY 2.0 MM CORTEX SCREW

K952272 is the FDA 510(k) clearance for TI. ALLOY 2.0 MM CORTEX SCREW by Synthes (Usa). It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K952272 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
77d
Days
Class 2
Risk

K952272 is an FDA 510(k) clearance for the TI. ALLOY 2.0 MM CORTEX SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on July 31, 1995 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes (Usa) devices

Submission Details

510(k) Number K952272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1995
Decision Date July 31, 1995
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 563
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K952272.
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
REUNION BONE SCREW SYSTEM
K951389 · Smith & Nephew Richards, Inc. · Jul 1995
ANSPACH SUTURE ANCHOR
K945525 · The Anspach Effort, Inc. · Jul 1995
ABSORBABLE ACETABULAR SCREW
K946347 · Zimmer, Inc. · Jul 1995