(192 days)
Not Found
No
The summary describes a mechanical implant for joint resurfacing and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is a hemi-arthroplasty system designed to resurface the 1st metatarsal head or the base of the proximal phalanx, treating arthritis and MTP joint issues, which clearly serves a therapeutic purpose.
No
This device is a surgical implant designed for resurfacing joints, not for diagnosing conditions.
No
The device description clearly states it consists of physical components (metatarsal and phalangeal components made from cobalt chromium alloy and titanium) designed for surgical implantation, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Ascension® Metal Great Toe System is an implantable device designed to be surgically placed inside the body to resurface a joint. It is a physical component used in a surgical procedure, not a test performed on a sample.
- Intended Use: The intended use is for the surgical treatment of arthritis in the first metatarsal joint by resurfacing the bone surfaces. This is a therapeutic intervention, not a diagnostic test.
Therefore, based on the provided information, the Ascension® Metal Great Toe System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1ª metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthroplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. Indications include:
- o Hallux valgus or Hallux limitus
- Hallux rigidus
- Unstable or painful metatarsal/phalangeal (MTP) ioint .
Product codes (comma separated list FDA assigned to the subject device)
KWD
Device Description
The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1ª metatarsal head or the base of the proximal phalanx. The components are anatomically designed, monolithic devices designed for resurfacing of the head of the 1st metatarsal or the phalangeal (MTP) joint. The devices are made from cobalt chromium alloy with a commercially pure titanium plasma spray. These devices are intended as hemi-arthroplasties at either surface and are press-fit.
Each device is boxed individually and delivered sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
1st metatarsal head or the base of the proximal phalanx, first metatarsal joint, metatarsal/phalangeal (MTP) 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)
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.
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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510(k) Summary
| SUBMITTER NAME: | Ascension Orthopedics, Inc.
8700 Cameron Road, #100
Austin, TX 78754-3832 | JAN 1 4 2011 |
|-----------------|---------------------------------------------------------------------------------|--------------|
| 510(k) CONTACT: | Debbie Stearns
Phone: (512) 836-5001 x1548 | |
| TRADE NAME: | Ascension® Metal Great Toe System | |
| COMMON NAME: | Toe joint phalangeal (hemi-toe) polymer prosthesis | |
| CLASSIFICATION: | 21 CFR 888.3730 (hemi) | |
| PRODUCT CODE: | KWD | |
| PANEL: | Orthopedic | |
PREDICATE DEVICES:
K031859 - CAP Great Toe Resurfacing Hemi-arthroplasty implant K023770 - K2 Hemi Toe Implant System
DEVICE DESCRIPTION:
The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1ª metatarsal head or the base of the proximal phalanx. The components are anatomically designed, monolithic devices designed for resurfacing of the head of the 1st metatarsal or the phalangeal (MTP) joint. The devices are made from cobalt chromium alloy with a commercially pure titanium plasma spray. These devices are intended as hemi-arthroplasties at either surface and are press-fit.
Each device is boxed individually and delivered sterile for single use.
INTENDED USE:
The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 18t metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemiarthroplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. Indications include:
- o Hallux valgus or Hallux limitus
- Hallux rigidus �
- Unstable or painful metatarsal/phalangeal (MTP) ioint .
BASIS OF SUBSTANTIAL EQUIVALENCE:
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K09.2047
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There are no significant differences between the Ascension Metal Great Toe System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with healthcare and medicine. The caduceus consists of a staff with two snakes coiled around it, topped with a pair of wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Ascension Orthopedics, Inc. % Ms. Debbie Steams Director, Regulatory/Clinical Affairs 8700 Cameron Road, #100 Austin, Texas 78754-3832
JAN 1 4 2010
Re: K092047
Trade/Device Name: Ascension Metal Great Toe System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: December 18, 2009 Received: December 22, 2009
Dear Ms. Steams:
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 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- Ms. Debbie Stearns
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Sincerely, yours,
Qaulaya Muehr
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(K) Number: K
Device Name:
Ascension® Metal Great Toe System
Indications for Use:
The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 18 metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemi-arthroplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. Indications include:
- . Hallux valgus or Hallux limitus
- Hallux rigidus 0
- Unstable or painful metatarsal/phalangeal (MTP) joint .
| Prescription Use
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | OR | Over-The-Counter Use | |
|---|---|---|---|
| 19 104 000 004 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | A March Comments of Children Company Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children |
(Part 21 CFR 801 Subpart B) C)
(Part 21 CFR 801Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smitt
Division Sign ded mrm
Wision Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092047
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