Cleared Traditional

K001571 - BAUMER FEMORAL HEAD

K001571 is an FDA 510(k) clearance for BAUMER FEMORAL HEAD, manufactured by Baumer, S.A. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K001571 · Baumer, S.A · Orthopedic device
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Aug 2000
Decision
74d
Days
Class 2
Risk

K001571 is an FDA 510(k) clearance for the BAUMER FEMORAL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Baumer, S.A (Mogi Mirim, Sao Paulo, BR). The FDA issued a Cleared decision on August 4, 2000 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Baumer, S.A devices

FDA 510(k) Submission Details - K001571

510(k) Number K001571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2000
Decision Date August 04, 2000
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 515
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K001571.
DEPUY C-STEM SYSTEM
K003421 · DePuy Orthopaedics, Inc. · Dec 2000
ONCOLOGY SALVAGE SYSTEM
K002757 · Biomet, Inc. · Nov 2000
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
K001759 · Implex Corp. · Aug 2000
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
K002106 · Biomet, Inc. · Jul 2000
TI-MAX PROTRUSIO CAGE
K001376 · Biomet, Inc. · Jul 2000
TORNIER CEMENT RESTRICTOR
K001932 · Tornier · Jul 2000