(227 days)
Not Found
No
The summary describes a physical implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an implant for hemi-arthroplasty to treat degenerative and post-traumatic arthritis, which are conditions that benefit from therapeutic intervention.
No
This device is an implantable Hemi-Arthroplasty system for the metatarsophalangeal joint, used in the treatment of arthritis. It is a therapeutic device inserted into a patient, not a device used to diagnose a medical condition.
No
The device description clearly indicates it is a physical implant (hemi-arthroplasty implant) made of components that mate together for fixation. It also mentions being used with bone cement and undergoing mechanical testing. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Hemi-Arthroplasty implant for the metatarsophalangeal joint" used for treating arthritis and other conditions in the foot. This is a surgical implant, not a device used to examine specimens derived from the human body.
- Device Description: The description details a physical implant designed to be surgically placed in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens. This device is used in vivo (inside the body) as a surgical implant.
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.
Product codes (comma separated list FDA assigned to the subject device)
KWD
Device Description
The HemiCAP® MTP Resurfacing Hemi-Arthroplasty System-Phalangeal HemiCAP® incorporates an articular resurfacing component and a cancellous taper post fixation 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 enclosed phalangeal base HemiCAP® implant is intended for hemiarthroplasty only. Do not use in conjunction with metallic metatarsal implant.
The present device modification includes the addition of modified phalangeal base (concave) implants and a corresponding taper post to the existing system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarsophalangeal joint, metatarsal joint, metatarsal/phalangeal (MTP) joint, phalangeal base
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)
- Comparative Engineering Analyses
- Comparative Mechanical Testing
- Assembly and Disassembly Testing
- Resistance to Torsion Testing
- Cyclic Fatigue Testing
- Fretting Corrosion Testing
- Pull-out Strength Testing
- Finite Element Analysis
The results have demonstrated the safety and effectiveness of the HemiCAP® MTP Resurfacing Hemi-Arthroplasty System-Phalangeal HemiCAP® Implants along with substantial equivalence to the predicate devices.
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.
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2016
Arthrosurface, Incorporated Ms. Dawn Wilson VP, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K152454
Trade/Device Name: HemiCAP® MTP Resurfacing Hemi-Arthroplasty System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: March 10, 2016 Received: March 14, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement Section 4
510(k) Number (if known): K152454
HemiCAP® MTP Resurfacing Hemi-Arthroplasty System Device Name:
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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Section 5 510(k) Summary
HemiCAP® MTP Resurfacing Hemi-Arthroplasty System Phalangeal HemiCAP®
Special 510(k) Submission: Device Modification
| 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
Tel: 508.520.3003
Fax: 508.528.4604
dwilson@arthrosurface.com |
| Establishment Registration
Number: | 3004154314 |
| Date of Preparation: | March 30th, 2016 |
| Confidentiality: | Reference Section 3 |
| Proprietary Name: | HemiCAP® MTP Resurfacing Hemi-
Arthroplasty System-Phalangeal HemiCAP® |
| Common Name: | MTP Hemi-Toe Prosthesis |
| Device: | Prosthesis, Toe, Hemi, Phalangeal |
| Regulation Description: | Toe joint phalangeal (hemi-toe) polymer
prosthesis |
| Regulation Number: | 888.3730 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
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Product Code: KWD
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.
Device Description
The HemiCAP® MTP Resurfacing Hemi-Arthroplasty System-Phalangeal HemiCAP® incorporates an articular resurfacing component and a cancellous taper post fixation 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 enclosed phalangeal base HemiCAP® implant is intended for hemiarthroplasty only. Do not use in conjunction with metallic metatarsal implant.
The present device modification includes the addition of modified phalangeal base (concave) implants and a corresponding taper post to the existing system.
Substantial Equivalence Information
Arthrosurface, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the HemiCAP® MTP Resurfacing Hemi-Arthroplasty System is substantially equivalent in indications and design principles to the following predicate devices, which have been previously cleared by the FDA:
- The sponsor's previously cleared CAP® Great Toe Resurfacing Hemi-
- Arthroplasty (K031859, Cleared on 02/18/2004)
- The sponsor's previously cleared HemiCAP® MTP Resurfacing Hemi-● Arthroplasty System (K131377, Cleared on 11/19/2013)
- . The sponsor's previously cleared Arthrosurface® Total Toe - Proximal Phalanx Implant (K132496, Cleared on 02/26/2014)
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The fundamental scientific technology of the proposed device has not changed relative to the predicate devices.
- Has the same Indications for Use, ●
- . Has the same operating principle,
- Is manufactured using the same material, ●
- Has the same shelf life, ●
- . Is packaged and sterilized using the same materials and processes.
In support of this submission, the following non-clinical tests and analyses have been performed on the Subject Device:
- Comparative Engineering Analyses .
- . Comparative Mechanical Testing
- Assembly and Disassembly Testing
- o Resistance to Torsion Testing
- Cyclic Fatigue Testing o
- Fretting Corrosion Testing o
- Pull-out Strength Testing
- Finite Element Analysis
The results have demonstrated the safety and effectiveness of the HemiCAP® MTP Resurfacing Hemi-Arthroplasty System-Phalangeal HemiCAP® Implants along with substantial equivalence to the predicate devices.