Cleared Traditional

K844482 - MULLER TITANIUM BACKED ACETABULAR CUP C...

K844482 is an FDA 510(k) clearance for MULLER TITANIUM BACKED ACETABULAR CUP C..., manufactured by Advanced Biosearch Assn.. The device is a Class 3 Orthopedic device with product code JDL cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K844482 · Advanced Biosearch Assn. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
92d
Days
Class 3
Risk

K844482 is an FDA 510(k) clearance for the MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Advanced Biosearch Assn. (Danville, US). The FDA issued a Cleared decision on February 19, 1985 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3320 - 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: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Biosearch Assn. devices

FDA 510(k) Submission Details - K844482

510(k) Number K844482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1984
Decision Date February 19, 1985
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

JDL Device Classification - Class 3, Premarket Approval

Product Code JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3320
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - JDL Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

All 34
Devices cleared under the same product code (JDL) and FDA review panel - the closest regulatory comparables to K844482.
DIMENSION TOTAL HIP PROSTHESIS POROUS COATED
K854107 · Kirschner Medical Corp. · Mar 1986
MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA
K850793 · Intermedics Orthopedics · May 1985
MICRO-STRUC. ACETABULAR COMPON- MC2P
K850352 · Osteonics Corp. · Apr 1985
DORR HIP PROSTHESIS, ACETABULAR COMPON
K842893 · Carbomedics, Inc. · Nov 1984
NATURAL LOCK ACETABULAR COMPONENT
K830662 · Advanced Biosearch Assn. · Apr 1983
101-32 FEMORAL COMPONENT
K813599 · Intermedics Orthopedics · Jan 1982