Cleared Traditional

K032894 - OSTEO ACL SCREW MODEL

Also marketed or referenced as:
237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,

K032894 is an FDA 510(k) clearance for OSTEO ACL SCREW MODEL, manufactured by Linvatec Biomaterials, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K032894 · Linvatec Biomaterials, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
233d
Days
Class 2
Risk

K032894 is an FDA 510(k) clearance for the OSTEO ACL SCREW MODEL. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Linvatec Biomaterials, Inc. (Tampere, FI). The FDA issued a Cleared decision on May 7, 2004 after a review of 233 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 Linvatec Biomaterials, Inc. devices

FDA 510(k) Submission Details - K032894

510(k) Number K032894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date May 07, 2004
Days to Decision 233 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
111d slower than avg
Panel avg: 122d · This submission: 233d
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 827
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K032894.
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
K040656 · Smith & Nephew, Inc. · May 2004
MICROMAX SUTURE ANCHOR
K040475 · Biomet, Inc. · May 2004
ENDOTINE TRANSBLEPH DEVICE
K040740 · Coapt Systems, Inc. · May 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331 · Smith & Nephew, Inc. · Apr 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · United States Surgical, A Division of Tyco Healthc · Mar 2004
BILOK ST SCREW
K033792 · Biocomposites, Ltd. · Mar 2004