Relief of pain and disability, and restoration of hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, with the bearing surface and supportive bone structure of the acetabulum being normal. The device is a single use implant intended to be used for cemented, hemi-hip, resurfacing applications only.

Device Description

The Contoured Articular Prosthetic (CAP) system is intended for resurfacing of the femoral head in patients with post-traumatic degenerative disease or avascular necrosis. The natural acetabulum bearing surface and supportive bone structure should be essentially normal. The device is a single use implant intended to be used with bone cement.

The CAP implant consists of two components, a fixation component and an articular component, that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface.

The fixation component is a modified cancellous screw manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The screw has a tapering distal tip, a full-length cannulation, and a proximal female taper bore.

The articular component is a dome shaped component manufactured of a Cobalt-Chromium-Molvbdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface.

Utilizing the drill quide provided within the CAP instrumentation set, a surgeon is able to define a working axis that is normal to the articular cartilage surface at the site of the defect. After drilling a pilot hole, the fixation component is screwed into place using the trial cap to ensure that the surface of the articular component will be tangent and congruent to the existing cartilage surface when seated. Using the contact probe instrument corresponding to the implant diameter, offset measurements are taken to define the topography of the patients surrounding articular surface by revolving the probe around a centering shaft coaxial to the working axis of the screw. With these offset measurements, the surgeon is able to select the articular component (sized to match femoral head sizes from 40mm to 58mm) that will allow it to seat flush to the surrounding articular surface. Offset increments in .5mm sizes will allow for an optimal fit to the existing articular cartilage.

A reamer, which matches the articular component internal geometry is used to prepare the site for the prosthetic to be implanted. This allows for a precise fit of the implant to the prepared site and minimizes bone resection, so as to provide minimal impact to any future arthroplasty procedure. The articular component is then impacted to seat the taper interlock between the two components.

The prosthetic is intended to provide an effective means for managing pain and disability in the younger patient until a total or joint arthroplasty treatment option becomes more necessary and less likely to create an early-age-revision scenario. The prosthetic may also provide a treatment option for the older patient who may not tolerate the morbidity of a total joint arthroplasty procedure.

AI/ML Overview

This 510(k) summary (K021549) describes the Contoured Articular Prosthetic (CAP) Femoral Head Resurfacing System but does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on:

Device Description: What the CAP system is, its components, materials, and how it is implanted.
Substantial Equivalence: Comparing the CAP system to legally marketed predicate devices (Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis and Nelson Resurfacing Head) based on intended use, indications for use, materials, design, and other features. This is the primary method of evaluation for 510(k) clearances, relying on the safety and effectiveness of previously cleared devices.
Regulatory Information: Classification, product code, and the FDA's decision letter of substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria from this document.

The specific details requested, such as sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, and standalone performance data, are typically found in more comprehensive clinical validation or performance studies, which are not included in a 510(k) summary. For medical devices cleared via 510(k), regulatory clearance is often based on demonstrating substantial equivalence to a predicate device, rather than requiring new, extensive clinical trials proving specific performance metrics against pre-defined acceptance criteria in the same way a PMA device might.

Summary

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K021549

510(K) Summary of Safety and Effectiveness

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the Contoured Articular Prosthetic (CAP) Femoral Head Resurfacing System.

Submitted By:	STD Manufacturing, Inc.1063 Turnpike StreetStoughton, MA 02072(781) 828-4400
Date:	May 6, 2002
Contact Person:	Steven W. EkVP Development
Proprietary Name:	Contoured Articular Prosthetic (CAP)Femoral Head Resurfacing System
Common Name:	Prosthesis, Hip, Hemi-, Resurfacing, Metallic
Classification Name:	Prosthesis, Hip, Femoral (Hemi-hip), Metallic ResurfacingOrthopedic21 CFR § 888.3400Class II
Product Code:	KXA

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Device Description:

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Substantial Equivalence Information:

Comparison Information
for Candidate and Predicate Devices
Product Name	Candidate Device:Contoured ArticularProsthesis (CAP) FemoralHead Resurfacing System	Predicate Device:Cormet 2000 Hemi Hip MetallicResurfacing Prosthesis	Predicate Device:Nelson Resurfacing Head
K Number	TBD	K994153	K983452
Product Code	KXA	KXA	KXA
RegulationNumber	888.3400	888.3400	888.3400
Intended Use	Resurfacing a portion of thefemoral head in patientswith post-traumaticdegenerative disease oravascular necrosis. Thedevice is a single useimplant intended to be usedwith bone cement.	Resurfacing a portion of the wornfemoral head, and so instatefunction of the hip joint following thedegenerative effects of osteo andrheumatoid arthritis, post traumaticdisease, and avascular necrosis.Also intended for patients havingdeformities of the hip that do notlend themselves to conventionaltotal hip replacement such aspreviously failed femoral osteotomy,previous fracture, or earlydeformities of the proximal end ofthe femur.	Resurfacing Prosthesis ofthe femoral hip joint (Hemi-Hip) for saving the naturalfemur and providing a newsurface on the femoral headfor the hip to pivot on. Forcemented applications andfor single use implantationin: non-inflammatorydegenerative joint disease,including osteoarthritis andavascular necrosis, andrheumatoid arthritis.
Indications forUse Statement	Relief of pain and disability,and restoration of hipfunction within patients whohave radiographic evidenceof good bone stock in thefemoral head andacetabulum, the bearingsurface and supportive bonestructure of the acetabulumbeing normal.	Relief of pain and disability, andrestoration of hip function withinpatients who have radiographicevidence of good bone stock inthe femoral head andacetabulum, the bearingsurface and supportive bonestructure of the acetabulumbeing normal.	Non-inflammatorydegenerative joint disease,including osteoarthritis andavascular necrosis andrheumatoid arthritis.
Patient Selection	Patients with pain or loss offunction, whose age at thetime of treatment suggeststhat a revision of theprosthetic is possible.	Patients with pain or loss offunction, whose age at the timeof treatment suggests that arevision of the prosthetic ispossible.	Patients with pain or loss offunction, whose age at thetime of treatment suggestthat a revision of theprosthetic is probable.
Material	Cobalt-Chromium-Molybdenum	Cobalt-Chromium-Molybdenum	Cobalt-Chromium-Molybdenum
Designed toResurface orReplaceArticular Surface	Femoral Head ResurfacingTechnique	Femoral Head ResurfacingTechnique	Femoral Head ResurfacingTechnique
Prostheticlmplant site andBearing Surface	Prosthetic implanted intohead of femur, replacingonly a small portion of thefemoral head.	Prosthetic implanted into headof femur, replacing only a smallportion of the femoral head.	Prosthetic implanted ontohead of femur, providingnew surface to femoralhead.
	Bearing surface contactsnatural acetabulum.	Bearing surface contactsnatural acetabulum.	Bearing surface contactsnatural acetabulum.

The intended use, materials, and application of the candidate device are substantially equivalent to those of the predicate devices as shown:

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ProductD scription	Candidate Device:Contoured ArticularProsthesis (CAP) FemoralHead Resurfacing System	Predicate Device:Cormet 2000 Hemi Hip MetallicResurfacing Prosthesis	Predicate Device:Nelson Resurfacing Head
K Number	TBD	K994153	K983452
MechanicalFixation	Fixation screw installed ascentral post. Prosthesismates into screw via taperinterlock.	Prosthetic press fits intoprepared femoral head.Prosthetic has a centralsmooth post which inserts intopilot in femoral head.	Prosthetic press fits ontoprepared femoral head.Prosthetic has a centralsmooth post which insertsinto pilot in femoral head.
Cemented / Non-Cemented	Cemented	Cemented	Cemented
Surface Coating	Yes/ Plasma Spray Ti	Yes/ Unknown	Yes/ Plasma Spray Ti
Site Preparation	Resection of articularsurface and bone	Resection of articular surfaceof femoral head	Resection of articularsurface of femoral head

Potential risks associated with this device are the same as with other joint prosthetic devices. These include, but are not limited to:

Reaction to the bone cement
Reaction to the implant materials .
Nerve palsy ●
. Embolus
Implant loosening/ migration
Infection .
Delayed wound healing ●
Damage to the implants ●
Excessive wear
. Hematoma
Need for Revision .
. Incomplete resolution of symptoms

A number of clinical benefits are offered by the device is technically very easy to implant, and offers the surgeon a high degree of precision and flexibility in sizing and fitting the articular component to the existing anatomy. A reduction in bone and articular cartilage resection is also offered over the predicate devices, providing a more physiologically normal joint in terms of load and impact distribution.

Additional materials, manufacturing, and performance data to support the safety and effectiveness of the CAP System are provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 1 2002

Mr. Steven W. Ek Vice President, Development STD Manufacturing 1063 Turnpike Street Stoughton, Massachusetts 02072

Re: K021549

Trade/Device Name: Contoured Articular Prosthesis (CAP) Femoral Head Resurfacing System Regulation Number: 21 CFR 888.3400 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Resurfacing Prosthesis Regulatory Class: Class II Product Code: KXA Dated: May 10, 2002 Received: May 13, 2002

Dear Mr. Ek:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Steven W. Ek

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Femoral Head Resurfacing Prosthesis

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801/109

Over-The Counter Use No

(Optional Format 1-2-96)

R. Mark Millhussen

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number _K021549

Regulation Number and Section

§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.(b)
Classification. Class II.