Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical components, surgical technique, and material properties of the implant. There is no mention of AI or ML being used in the device itself, the surgical planning, or the post-operative analysis.

Therapeutic

Yes

The device is an implant intended to relieve pain and disability and restore hip function, which falls under the definition of a therapeutic device.

Diagnostic

No

This device is described as an implantable prosthetic, specifically for resurfacing the femoral head. Its purpose is to relieve pain and disability, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components made of metal alloys (Ti-6Al-4V ELI, Cobalt-Chromium-Molvbdenum) and describes a surgical implantation procedure involving instruments like drills, reamers, and probes. This indicates a hardware-based medical device, not a software-only one.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes.
Device Description and Intended Use: The description clearly states that this device is a surgical implant intended for resurfacing the femoral head in patients with specific hip conditions. It is a physical device implanted into the body to restore function and relieve pain.
Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient. The device interacts directly with the patient's bone and joint.

Therefore, the Contoured Articular Prosthetic (CAP) system falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Resurfacing a portion of the femoral head in patients with post-traumatic degenerative disease or avascular necrosis. The device is a single use implant intended to be used with bone cement.
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, the bearing surface and supportive bone structure of the acetabulum being normal.
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.

Product codes (comma separated list FDA assigned to the subject device)

KXA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

femoral head, hip joint

Indicated Patient Age Range

younger patient (for surgical option), older patient (who may not tolerate morbidity of total joint arthroplasty)

Intended User / Care Setting

Surgeon

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K994153, K983452

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 Street
Stoughton, MA 02072
(781) 828-4400 |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Date: | May 6, 2002 |
| Contact Person: | Steven W. Ek
VP 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 Resurfacing
Orthopedic
21 CFR § 888.3400
Class II |
| Product Code: | KXA |

1

page 2 of 4

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.

2

Substantial Equivalence Information:

Comparison Information
for Candidate and Predicate Devices
Product Name	Candidate Device:
Contoured Articular
Prosthesis (CAP) Femoral
Head Resurfacing System	Predicate Device:
Cormet 2000 Hemi Hip Metallic
Resurfacing Prosthesis	Predicate Device:
Nelson Resurfacing Head
K Number	TBD	K994153	K983452
Product Code	KXA	KXA	KXA
Regulation
Number	888.3400	888.3400	888.3400
Intended Use	Resurfacing a portion of the
femoral head in patients
with post-traumatic
degenerative disease or
avascular necrosis. The
device is a single use
implant intended to be used
with bone cement.	Resurfacing a portion of the worn
femoral head, and so instate
function of the hip joint following the
degenerative effects of osteo and
rheumatoid arthritis, post traumatic
disease, and avascular necrosis.
Also intended for patients having
deformities of the hip that do not
lend themselves to conventional
total hip replacement such as
previously failed femoral osteotomy,
previous fracture, or early
deformities of the proximal end of
the femur.	Resurfacing Prosthesis of
the femoral hip joint (Hemi-
Hip) for saving the natural
femur and providing a new
surface on the femoral head
for the hip to pivot on. For
cemented applications and
for single use implantation
in: non-inflammatory
degenerative joint disease,
including osteoarthritis and
avascular necrosis, and
rheumatoid arthritis.
Indications for
Use Statement	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, the bearing
surface and supportive bone
structure of the acetabulum
being normal.	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, the bearing
surface and supportive bone
structure of the acetabulum
being normal.	Non-inflammatory
degenerative joint disease,
including osteoarthritis and
avascular necrosis and
rheumatoid arthritis.
Patient Selection	Patients with pain or loss of
function, whose age at the
time of treatment suggests
that a revision of the
prosthetic is possible.	Patients with pain or loss of
function, whose age at the time
of treatment suggests that a
revision of the prosthetic is
possible.	Patients with pain or loss of
function, whose age at the
time of treatment suggest
that a revision of the
prosthetic is probable.
Material	Cobalt-Chromium-
Molybdenum	Cobalt-Chromium-
Molybdenum	Cobalt-Chromium-
Molybdenum
Designed to
Resurface or
Replace
Articular Surface	Femoral Head Resurfacing
Technique	Femoral Head Resurfacing
Technique	Femoral Head Resurfacing
Technique
Prosthetic
lmplant site and
Bearing Surface	Prosthetic implanted into
head of femur, replacing
only a small portion of the
femoral head.	Prosthetic implanted into head
of femur, replacing only a small
portion of the femoral head.	Prosthetic implanted onto
head of femur, providing
new surface to femoral
head.
	Bearing surface contacts
natural acetabulum.	Bearing surface contacts
natural acetabulum.	Bearing surface contacts
natural acetabulum.

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

3

| Product
D scription | Candidate Device:
Contoured Articular
Prosthesis (CAP) Femoral
Head Resurfacing System | Predicate Device:
Cormet 2000 Hemi Hip Metallic
Resurfacing Prosthesis | Predicate Device:
Nelson Resurfacing Head |
|-----------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | TBD | K994153 | K983452 |
| Mechanical
Fixation | Fixation screw installed as
central post. Prosthesis
mates into screw via taper
interlock. | Prosthetic press fits into
prepared femoral head.
Prosthetic has a central
smooth post which inserts into
pilot in femoral head. | Prosthetic press fits onto
prepared femoral head.
Prosthetic has a central
smooth post which inserts
into 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 articular
surface and bone | Resection of articular surface
of femoral head | Resection of articular
surface 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.

4

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.

5

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

6

510(k) Number (if known):

Device Name: Femoral Head Resurfacing Prosthesis

Indications for Use:

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.

(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