Cleared Traditional

K896614 - S.A.F. ACETABULAR CUP WITH POROUS COATING

K896614 is an FDA 510(k) clearance for S.A.F. ACETABULAR CUP WITH POROUS COATING, manufactured by Synergy Orthopaedics Intl., Inc.. The device is a Class 3 Orthopedic device with product code JDL cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K896614 · Synergy Orthopaedics Intl., Inc. · Orthopedic device
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Jan 1990
Decision
49d
Days
Class 3
Risk

K896614 is an FDA 510(k) clearance for the S.A.F. ACETABULAR CUP WITH POROUS COATING. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Synergy Orthopaedics Intl., Inc. (Indianapolis, US). The FDA issued a Cleared decision on January 9, 1990 after a review of 49 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.

FDA 510(k) Submission Details - K896614

510(k) Number K896614 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 21, 1989
Decision Date January 09, 1990
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 39
Devices cleared under the same product code (JDL) and FDA review panel - the closest regulatory comparables to K896614.
HEALEY REVISION COMPONENT SYSTEM
K921139 · Biomet, Inc. · Jul 1992
PCA ACETABULAR INSERT II
K921384 · Howmedica Corp. · Jun 1992
ACETABULAR DOME AND SCREW HOLE PLUGS
K920868 · Osteonics Corp. · May 1992
POROUS-COATED TITANIUM ACETABULAR CUP
K894965 · Dow Corning Wright · Nov 1989
POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
K895607 · Exactech, Inc. · Nov 1989
PNEUMOTHORAX KIT, MOTIFICATION
K892640 · Arrow Intl., Inc. · Oct 1989
K896614 · S.A.F. ACETABULAR CUP WITH POROUS COATING
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