Cleared Traditional

K934440 - PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES

K934440 is an FDA 510(k) clearance for PCA ACETABULAR INSERT II, manufactured by Howmedica Corp.. The device is a Class 3 Orthopedic device with product code JDL cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K934440 · Howmedica Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 1994
Decision
231d
Days
Class 3
Risk

K934440 is an FDA 510(k) clearance for the PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 231 days - an extended review 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K934440

510(k) Number K934440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date February 22, 1994
Days to Decision 231 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 122d · This submission: 231d
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 38
Devices cleared under the same product code (JDL) and FDA review panel - the closest regulatory comparables to K934440.
ACETABULAR DOME HOLE PLUGS
K942809 · Osteonics Corp. · Sep 1994
S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG
K931676 · Joint Medical Products Corp. · May 1994
PCA(R) SOLID BACK ACETABULA SHELL
K930833 · Howmedica Corp. · Feb 1994
SYRIGENE PRE-FILLED SYRINGE
K935669 · Regulatory & Marketing Services, Inc. · Feb 1994
CONSENSUS(TM) TOTAL HIP SYSTEM
K922561 · U.S. Medical Products, Inc. · Jul 1993
BIOMETRIC SCREW FIXATION CUP
K922861 · Osteo Technology, Inc. · May 1993