Cleared Traditional

K970829 - PHUSIS ABSORBABLE INTERFERENCE SCREW

K970829 is the FDA 510(k) clearance for PHUSIS ABSORBABLE INTERFERENCE SCREW by Tornier. It is a Class 2 Orthopedic device (product code HWC) cleared through the Traditional 510(k) pathway after a 656-day FDA review.

K970829 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
656d
Days
Class 2
Risk

K970829 is an FDA 510(k) clearance for the PHUSIS ABSORBABLE INTERFERENCE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Tornier (Concord, US). The FDA issued a Cleared decision on December 22, 1998 after a review of 656 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Tornier devices

Submission Details

510(k) Number K970829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1997
Decision Date December 22, 1998
Days to Decision 656 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
534d slower than avg
Panel avg: 122d · This submission: 656d
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 555
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K970829.
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED
K984209 · Biomet, Inc. · Feb 1999
SULZER ORTHOPEDICS SYSORB INTERFERENCE SCREWS
K983592 · Sulzer Orthopedics, Inc. · Jan 1999
BIOABSORBABLE INTERFERENCE SCREWS
K984320 · Smith & Nephew, Inc. · Jan 1999
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508 · Osteonics Corp. · Dec 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K983165 · Osteonics Corp. · Dec 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
K982662 · DePuy Orthopaedics, Inc. · Oct 1998