Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: JDL FDA class 3

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Orthopedic

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A semi-constrained metal cemented acetabular component hip prosthesis is an implantable device that replaces the acetabular socket in total hip arthroplasty, fixed to the pelvis with bone cement, providing partial constraint to the articulation while allowing controlled hip motion. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) demonstrating safety and effectiveness prior to marketing. The product code is JDL, regulated under 21 CFR 888.3320, within the Orthopedic medical specialty. This device is an implant.

510(k) Clearances

45 matches

K Number

Device Name

Decision Date

Decision

Applicant

K073499

VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES

Aug 07, 2008

Substantially Equivalent

ZIMMER, INC.

K070785

DYNASTY ACETABULAR SYSTEM

Jul 11, 2007

Substantially Equivalent

WRIGHT MEDICAL TECHNOLOGY, INC.

K061844

DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER

Dec 06, 2006

Substantially Equivalent

WRIGHT MEDICAL TECHNOLOGY, INC.

K051995

PROFEMUR RENAISSANCE HIP STEM

Aug 22, 2005

Substantially Equivalent

WRIGHT MEDICAL TECHNOLOGY, INC.

K051348

CONSERVE TOTAL FEMORAL HEAD

Aug 19, 2005

Substantially Equivalent

WRIGHT MEDICAL TECHNOLOGY, INC.

K042841

M2A/C2A ACETABULAR SYSTEM

Dec 21, 2004

Substantially Equivalent

BIOMET, INC.

K041586

PROFEMUR S HIP STEM

Jul 09, 2004

Substantially Equivalent

WRIGHT MEDICAL TECHNOLOGY, INC.

K041114

PROFEMUR TAPERED HIP STEM

May 28, 2004

Substantially Equivalent

WRIGHT MEDICAL TECHNOLOGY, INC.

K004043

METAL TRANSCEND ARTICULATION SYSTEM

Jul 13, 2001

Substantially Equivalent

WRIGHT MEDICAL TECHNOLOGY, INC.

K950542

METAL BACKED ACETABULAR COMPONENT

May 25, 1995

Substantially Equivalent

ENCORE ORTHOPEDICS, INC.

K944769

P.F.C. APICAL PLUG

Dec 08, 1994

Substantially Equivalent

JOHNSON & JOHNSON PROFESSIONALS, INC.

K942809

ACETABULAR DOME HOLE PLUGS

Sep 20, 1994

Substantially Equivalent

OSTEONICS CORP.

K931676

S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG

May 18, 1994

Substantially Equivalent

JOINT MEDICAL PRODUCTS CORP.

K934440

PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES

Feb 22, 1994

Substantially Equivalent

HOWMEDICA CORP.

K930833

PCA(R) SOLID BACK ACETABULA SHELL

Feb 22, 1994

Substantially Equivalent

HOWMEDICA CORP.

K935669

SYRIGENE PRE-FILLED SYRINGE

Feb 18, 1994

Substantially Equivalent

REGULATORY & MARKETING SERVICES, INC.

K922561

CONSENSUS(TM) TOTAL HIP SYSTEM

Jul 21, 1993

Substantially Equivalent

U.S. MEDICAL PRODUCTS, INC.

K915529

FPC/SFPC/RFPC ACETABULAR COMPONENT

Jul 13, 1993

Substantially Equivalent

IMPLANTOLOGY CORP.

K915527

CPS ACETABULAR COMPONENT

Jun 24, 1993

Substantially Equivalent

IMPLANTOLOGY CORP.

K922861

BIOMETRIC SCREW FIXATION CUP

May 12, 1993

Substantially Equivalent

OSTEO TECHNOLOGY, INC.

K920929

POLY INSERT 20 DEGREE

May 05, 1993

Substantially Equivalent

DOW CORNING WRIGHT

K925181

TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP

Feb 05, 1993

Substantially Equivalent

TECHMEDICA, INC.

K921139

HEALEY REVISION COMPONENT SYSTEM

Jul 01, 1992

Substantially Equivalent

BIOMET, INC.

K921384

PCA ACETABULAR INSERT II

Jun 25, 1992

Substantially Equivalent

HOWMEDICA CORP.

K920868

ACETABULAR DOME AND SCREW HOLE PLUGS

May 26, 1992

Substantially Equivalent

OSTEONICS CORP.

K896614

S.A.F. ACETABULAR CUP WITH POROUS COATING

Jan 09, 1990

Substantially Equivalent for Some Indications

SYNERGY ORTHOPAEDICS INTL., INC.

K895607

POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT

Nov 17, 1989

Substantially Equivalent for Some Indications

EXACTECH, INC.

K894965

POROUS-COATED TITANIUM ACETABULAR CUP

Nov 17, 1989

Substantially Equivalent for Some Indications

DOW CORNING WRIGHT

K892640

PNEUMOTHORAX KIT, MOTIFICATION

Oct 11, 1989

Substantially Equivalent

ARROW INTL., INC.

K870867

KM-4(TM) METAL-BACKED ACETABULAR CUP

May 08, 1987

Substantially Equivalent

KIRSCHNER MEDICAL CORP.

K870234

P.T.H. METAL-BACKED ACETABULAR CUP

Mar 20, 1987

Substantially Equivalent

ORTHOPAEDIC DEVICE CORP.

K861264

JOINT MEASUREMENT INDICATOR

Apr 15, 1986

Substantially Equivalent

DEVCOM, INC.

K855042

KM-3 ACETABULAR COMPONENT

Mar 14, 1986

Substantially Equivalent for Some Indications

KIRSCHNER MEDICAL CORP.

K854107

DIMENSION TOTAL HIP PROSTHESIS POROUS COATED

Mar 10, 1986

Substantially Equivalent for Some Indications

KIRSCHNER MEDICAL CORP.

K854935

LINK METAL-BACKED ACETABULAR CUPS

Mar 05, 1986

Substantially Equivalent

LINK AMERICA, INC.

K852369

LIDGRER-LUND ACETABULAR SOCKETS

Jun 18, 1985

Substantially Equivalent

LINK AMERICA, INC.

K850793

MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA

May 09, 1985

Substantially Equivalent

INTERMEDICS ORTHOPEDICS

K850352

MICRO-STRUC. ACETABULAR COMPON- MC2P

Apr 25, 1985

Substantially Equivalent

OSTEONICS CORP.

K844482

MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT

Feb 19, 1985

Substantially Equivalent

ADVANCED BIOSEARCH ASSN.

K842893

DORR HIP PROSTHESIS, ACETABULAR COMPON

Nov 08, 1984

Substantially Equivalent

CARBOMEDICS, INC.

K831792

SELF-ALIGNING ACETABULAR COMPONENT

Sep 20, 1984

Substantially Equivalent

ENDOMEDICS, INC.

K830662

NATURAL LOCK ACETABULAR COMPONENT

Apr 11, 1983

Substantially Equivalent

ADVANCED BIOSEARCH ASSN.

K813599

101-32 FEMORAL COMPONENT

Jan 22, 1982

Substantially Equivalent

INTERMEDICS ORTHOPEDICS

K790274

BG PROXIMAL FEMUR

Mar 26, 1979

Substantially Equivalent

HOWMEDICA CORP.

K770472

PROSTHESIS, VIDAL TOTAL HIP

Mar 17, 1977

Substantially Equivalent

HOWMEDICA CORP.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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