Cleared Traditional

K910548 - FELDMUEHLE CERAMIC HEAD (12/14 X 32MM)

K910548 is an FDA 510(k) clearance for FELDMUEHLE CERAMIC HEAD (12/14 X 32MM), manufactured by Turnkey Intergration USA, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K910548 · Turnkey Intergration USA, Inc. · Orthopedic device
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Apr 1991
Decision
61d
Days
Class 2
Risk

K910548 is an FDA 510(k) clearance for the FELDMUEHLE CERAMIC HEAD (12/14 X 32MM). Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Turnkey Intergration USA, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 9, 1991 after a review of 61 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 Turnkey Intergration USA, Inc. devices

FDA 510(k) Submission Details - K910548

510(k) Number K910548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1991
Decision Date April 09, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 122d · This submission: 61d
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 451
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K910548.
KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL
K912295 · Kinamed, Inc. · Aug 1991
ZIRCONIA CERAMIC MODULAR HEADS
K905687 · Biomet, Inc. · Apr 1991
FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)
K910547 · Turnkey Intergration USA, Inc. · Apr 1991
ZIMMER CERAMIC FEMORAL HEADS
K905739 · Zimmer, Inc. · Mar 1991
TOTAL HIP FEMORAL COMPONENT
K905260 · Intermedics Orthopedics · Jan 1991
DCW MODULAR PROXIMAL FEMORAL SYSTEM
K904028 · Dow Corning Wright · Jan 1991