(189 days)
Not Found
No
The summary describes a physical implant for joint resurfacing and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is an implantable medical device used to treat arthritis and other conditions in the metatarsal joint, which is a therapeutic purpose.
No
The device is described as an implant for treating arthritis, not for diagnosing conditions.
No
The device description clearly describes a physical implant (articular resurfacing component and cancellous taper post component) intended for surgical implantation, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating arthritis in the metatarsophalangeal joint. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details a physical implant designed to be surgically placed within the joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
Hemi-Arthroplasty Implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement.
Product codes
KWD
Device Description
The HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant incorporates an articular resurfacing component and a cancellous taper post 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 HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant is a single use implant with updated indications for use with or without bone cement to be consistent with predicates, and updated general terminology for MTP. The implant is otherwise identical to the sponsor's previously cleared and commercially marketed implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarsophalangeal joint, metatarsal joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Clinical data was provided in support of the substantial equivalency. Data was obtained from over 100 patients with follow-up ranging out to 5 years. Results demonstrated the safety and effectiveness of the HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant is adequately supported by the substantial equivalence information provided within this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.
0
NOV 1 9 2013
Section 5 510(k) Summary
| 510(k) Owner: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038
Tel: 508.520.3003
Fax: 508.528.4604 |
|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Wilson
VP, Quality & Regulatory |
| Date of Preparation: | May 13, 2013 |
| Trade Name: | HemiCAP® MTP Resurfacing Hemi-Arthroplasty
Implant |
| Common Name: | MTP hemi-toe prosthesis |
| Device:
Regulation Number:
Regulation Name:
Device Class:
Review Panel:
Product Code: | Prosthesis, Toe, Hemi-, Phalangeal
21 CFR 888.3730
Toe joint phalangeal (hemi-toe) polymer prosthes
Class II
Orthopedic
KWD |
Device Intended Use
Hemi-Arthroplasty Implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement.
Device Description
The HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant incorporates an articular resurfacing component and a cancellous taper post 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.
1
Materials
Articular Resurfacing Component: Cobalt-Chromium Alloy (Co-Cr-Mo) Surface Coating: Titanium (CP Ti) Taper Post Component: Titanium Alloy (Ti-6Al-4V)
The HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant is a single use implant with updated indications for use with or without bone cement to be consistent with predicates, and updated general terminology for MTP. The implant is otherwise identical to the sponsor's previously cleared and commercially marketed implant.
Referencing predicate devices, similar indications have been cleared since 2007. Such history of use demonstrates the differences in indications are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, nor do they affect the safety and effectiveness of the device when used as labeled.
Substantial Equivalency:
The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices:
| • CAP™ Great Toe Resurfacing Hemi-Arthroplasty Implant | K031859 |
|---|---|
| • Solana Surgical LLC, Metatarsal Decompression Implant | K113752 |
-
Vilex Cannulated Metallic Hemi Implant . K102401
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices: -
Intended for the metatarsophalangeal joint .
-
Similar indications for use .
-
. Similar device designs
-
o Same Cobalt and Titanium implant materials
-
Implants available anatomically curved .
-
Similar fixation options .
Clinical data was provided in support of the substantial equivalency. Data was obtained from over 100 patients with follow-up ranging out to 5 years. Results demonstrated the safety and effectiveness of the HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant is adequately supported by the substantial equivalence information provided within this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a bird or abstract human figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2013
Arthrosurface, Incorporated Ms. Dawn J. Wilson Vice President of Quality and Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K131377
Trade/Device Name: HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: November 5, 2013 Received: November 6, 2013
Dear Ms. Wilson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Dawn J. Wilson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Lori A. Wigqins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 Indications for Use Statement
510(k) Number (if known): K131377
Device Name: HemiCAP® MTP Resurfacing Hemi-Arthroplasty Implant
Indications for Use:
Hemi-Arthroplasty Implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ΠΠ
Casey L-Hanley, Ph.D.
١٦٢٦
10/11/
Division of Orthopedic Devices