Cleared Traditional

K971297 - CENTRE-DRIVE DRILL-FREE SCREW

K971297 is an FDA 510(k) clearance for CENTRE-DRIVE DRILL-FREE SCREW, manufactured by KLS-Martin L.P.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K971297 · KLS-Martin L.P. · Orthopedic device
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May 1997
Decision
30d
Days
Class 2
Risk

K971297 is an FDA 510(k) clearance for the CENTRE-DRIVE DRILL-FREE SCREW. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on May 8, 1997 after a review of 30 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 KLS-Martin L.P. devices

FDA 510(k) Submission Details - K971297

510(k) Number K971297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1997
Decision Date May 08, 1997
Days to Decision 30 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
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 1075
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K971297.
EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES
K961719 · Howmedica Leibinger, Inc. · Jul 1997
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K971321 · Osteonics Corp. · Jul 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES
K970258 · Ferguson Medical · May 1997
DEPUY ACE TROCHANTERIC SIDE PLATE
K970503 · Depuy Ace Medical Co. · Apr 1997
SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K963325 · Synthes (Usa) · Mar 1997
RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
K961498 · Howmedica, Inc. · Feb 1997