Cleared Traditional

K830662 - NATURAL LOCK ACETABULAR COMPONENT

K830662 is an FDA 510(k) clearance for NATURAL LOCK ACETABULAR COMPONENT, 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 39-day FDA review.

K830662 · Advanced Biosearch Assn. · Orthopedic device
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Apr 1983
Decision
39d
Days
Class 3
Risk

K830662 is an FDA 510(k) clearance for the NATURAL LOCK ACETABULAR COMPONENT. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Advanced Biosearch Assn. (Walker, US). The FDA issued a Cleared decision on April 11, 1983 after a review of 39 days - a notably fast clearance cycle.

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 - K830662

510(k) Number K830662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1983
Decision Date April 11, 1983
Days to Decision 39 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
83d faster than avg
Panel avg: 122d · This submission: 39d
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 K830662.
MICRO-STRUC. ACETABULAR COMPON- MC2P
K850352 · Osteonics Corp. · Apr 1985
MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT
K844482 · Advanced Biosearch Assn. · Feb 1985
DORR HIP PROSTHESIS, ACETABULAR COMPON
K842893 · Carbomedics, Inc. · Nov 1984
101-32 FEMORAL COMPONENT
K813599 · Intermedics Orthopedics · Jan 1982
BG PROXIMAL FEMUR
K790274 · Howmedica Corp. · Mar 1979
PROSTHESIS, VIDAL TOTAL HIP
K770472 · Howmedica Corp. · Mar 1977