Cleared Traditional

K981302 - SMC 28MM CERAMIC FEMORAL HEADS

K981302 is an FDA 510(k) clearance for SMC 28MM CERAMIC FEMORAL HEADS, manufactured by Signal Medical Corp.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K981302 · Signal Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
77d
Days
Class 2
Risk

K981302 is an FDA 510(k) clearance for the SMC 28MM CERAMIC FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Signal Medical Corp. (Lakeport, US). The FDA issued a Cleared decision on June 25, 1998 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Signal Medical Corp. devices

FDA 510(k) Submission Details - K981302

510(k) Number K981302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1998
Decision Date June 25, 1998
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 483
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K981302.
FOUNDATION POROUS HIP STEM
K991226 · Encore Orthopedics, Inc. · Jun 1999
TYPE 3 FEMORAL COMPONENTS
K983404 · Howmedica Corp. · Dec 1998
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K981847 · Smith & Nephew, Inc. · Jul 1998
OSTEOLOCK ACETABULAR CUP
K981201 · Howmedica Corp. · May 1998
OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS
K980774 · Osteonics Corp. · Apr 1998
PARTNERSHIP CALCAR FEMORAL COMPONENTS
K980239 · Howmedica, Inc. · Apr 1998