Cleared Traditional

K951415 - LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW

K951415 is an FDA 510(k) clearance for LUHR PAN FIXATION SYSTEM CONDENSED STRA..., manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K951415 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
86d
Days
Class 2
Risk

K951415 is an FDA 510(k) clearance for the LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE 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 Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 86 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K951415

510(k) Number K951415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1995
Decision Date June 22, 1995
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 1222
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K951415.
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
K953714 · Zimmer, Inc. · Nov 1995
ORTHOPEDIC BONE PLATE
K932352 · Osteomed Corp. · Jul 1995
LINK ENDO MODEL REVISION CUP
K943986 · Turnkey Intergration USA, Inc. · Jul 1995
LUHR TITANIUM ALLOY PAN FIXATION SYSTEM
K945137 · Howmedica Corp. · Jun 1995
LUHR TITANIUM PAN FIXATION SYSTEM
K945139 · Howmedica Corp. · Jun 1995
ORTHOMET ACETABULAR ROOF REINFORCEMENT RING
K944856 · Wrightmedicaltechnologyinc · May 1995