Cleared Traditional

K040701 - SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS

K040701 is an FDA 510(k) clearance for SYNTHES (USA) HYDROXYAPATITE (HA) COATE..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K040701 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
90d
Days
Class 2
Risk

K040701 is an FDA 510(k) clearance for the SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS. 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 June 15, 2004 after a review of 90 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K040701

510(k) Number K040701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2004
Decision Date June 15, 2004
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 923
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K040701.
RESORBABLE INTERFERENCE SCREW
K041274 · Arthrotek, Inc. · Jul 2004
LACTOSCREW SCREW ANCHOR
K033355 · Biomet Orthopedics, Inc. · Jun 2004
BIO-EUROLIG INTERFERENCE SCREW
K031939 · Fournitures Hospitalieres Industrie · Jun 2004
LITTLE GRAFTER SCREW
K040265 · Biocomposites, Ltd. · May 2004
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
K040656 · Smith & Nephew, Inc. · May 2004
MICROMAX SUTURE ANCHOR
K040475 · Biomet, Inc. · May 2004