Cleared Traditional

K954485 - 6.5MM SOLID CANCELLOUS BONE SCREW

K954485 is an FDA 510(k) clearance for 6.5MM SOLID CANCELLOUS BONE SCREW, manufactured by Ace Medical Co.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K954485 · Ace Medical Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
34d
Days
Class 2
Risk

K954485 is an FDA 510(k) clearance for the 6.5MM SOLID CANCELLOUS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Ace Medical Co. (El Segundo, US). The FDA issued a Cleared decision on October 31, 1995 after a review of 34 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 Ace Medical Co. devices

FDA 510(k) Submission Details - K954485

510(k) Number K954485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1995
Decision Date October 31, 1995
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
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 734
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K954485.
FIXANO D.D.S. (DOUBLE SLIDING SCREW)
K954757 · Ferguson Medical · Jan 1996
SUPER SCREW 3.5 MM
K954330 · Osteomed Corp. · Dec 1995
DEPUY STAINLESS STEEL SET SCREW
K953650 · Depuy, Inc. · Nov 1995
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