Cleared Traditional

K854107 - DIMENSION TOTAL HIP PROSTHESIS POROUS C...

K854107 is an FDA 510(k) clearance for DIMENSION TOTAL HIP PROSTHESIS POROUS C..., manufactured by Kirschner Medical Corp.. The device is a Class 3 Orthopedic device with product code JDL cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K854107 · Kirschner Medical Corp. · Orthopedic device
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Mar 1986
Decision
153d
Days
Class 3
Risk

K854107 is an FDA 510(k) clearance for the DIMENSION TOTAL HIP PROSTHESIS POROUS COATED. Classified as Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (product code JDL), Class III - Premarket Approval.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on March 10, 1986 after a review of 153 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 Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K854107

510(k) Number K854107 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 08, 1985
Decision Date March 10, 1986
Days to Decision 153 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
31d slower than avg
Panel avg: 122d · This submission: 153d
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 30
Devices cleared under the same product code (JDL) and FDA review panel - the closest regulatory comparables to K854107.
PNEUMOTHORAX KIT, MOTIFICATION
K892640 · Arrow Intl., Inc. · Oct 1989
KM-4(TM) METAL-BACKED ACETABULAR CUP
K870867 · Kirschner Medical Corp. · May 1987
KM-3 ACETABULAR COMPONENT
K855042 · 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
101-32 FEMORAL COMPONENT
K813599 · Intermedics Orthopedics · Jan 1982