Cleared Traditional

K982553 - OSTEO COMPRESSION HIP SCREW SYSTEM

K982553 is an FDA 510(k) clearance for OSTEO COMPRESSION HIP SCREW SYSTEM, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K982553 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
62d
Days
Class 2
Risk

K982553 is an FDA 510(k) clearance for the OSTEO COMPRESSION HIP SCREW SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K982553

510(k) Number K982553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1998
Decision Date September 22, 1998
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 1276
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K982553.
HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
K982531 · Howmedica Corp. · Oct 1998
MINI-FIXATOR FOR COLLES FRACTURES
K982982 · Biomet, Inc. · Oct 1998
SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
K982732 · Synthes · Oct 1998
DEPUY MOTECH PEAK FIXATION SYSTEM
K982483 · DePuy Orthopaedics, Inc. · Sep 1998
DEPUY ACE TIMAX PILON PLATE
K982347 · Depuy Ace Medical Co. · Aug 1998
MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)
K972913 · Pacific Materials and Interfaces · Jul 1998