(105 days)
No
The document describes a physical implant and surgical instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a prosthesis intended to treat painful degenerative metatarso-phalangeal joint changes, hallux rigidus, hallux valgus, hallux limitus, and for revisions after phalanx resection. It clearly aims to restore the function of the MTP joint, which is a therapeutic purpose.
No
Explanation: The device is described as a prosthetic implant for joint replacement, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a "two-piece implant" and describes physical components like stems and geometries, indicating it is a hardware medical device, not software-only.
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 prosthesis for the metatarsophalangeal joint (MTP). This is a surgical implant used in the body to replace a joint.
- Device Description: The description details a physical implant designed for surgical implantation and cemented fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples. This device is used inside the body as a replacement joint.
N/A
Intended Use / Indications for Use
The Ascension® MOVEMENT™ Great Toe System, Total Arthroplasty is a twopiece implant that is intended to be used as prosthesis for the metatarsophalangeal joint (MTP). The device is intended for cemented use only. Indications for use include:
- Painful degenerative metatarso-phalangeal joint change .
- Hallux rigidus stage 3 and 4 ◆
- Hallux valgus and hallux rigidus .
- Hallux limitus with painful arthrofibrosis .
- Revisions after moderate proximal phalanx resection .
Product codes
LZJ
Device Description
The Ascension® MOVEMENT Great Toe System, Total Arthroplasty device is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device couples with the Ascension metatarsal hemi-arthroplasty device to allow total arthroplasty of the 1st MTP joint. The device is designed for cemented fixation. The device is boxed individually and delivered sterile for single use. The device incorporates four anatomically designed base geometries with appropriately sized stems. The stem is cylindrical with tapered ribs to provide rotational as well as axial stability of the seated implant. System instrumentation is designed to offer precise implant preparation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarso-phalangeal joint (MTP)
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
Substantial equivalence was based upon testing and a geometrical comparison of the subject and predicate devices. Interconnection strength testing, axial, shear and bending strength, was performed to substantiate equivalence. Geometrical comparisons between the subject device, Ascension® MOVEMENT™ Great Toe System and Integra KGTI™ Kinetik Great Toe Implant System (K904724) were completed. The Merete ToeMobile Anatomical Great Toe Resurfacing System (K072251) was used as a template for labeled indications.
Key Metrics
Not Found
Predicate Device(s)
KGTI™ Kinetik Great Toe Implant System, Integra Lifesciences, K924724
Reference Device(s)
Merete ToeMobile™ Anatomical Great Toe Resurfacing System, Merete Medical, K072251
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K102549 1/2
501(k) Summary
DEC 2 1 2010
.
| SUBMITTER NAME: | Ascension Orthopedics, Inc.
8700 Cameron Road, #100
Austin, TX 78754-3832 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Susan Walton
Phone: (512) 836-5001 x1591 |
| TRADE NAME: | Ascension® MOVEMENT Great Toe System |
| COMMON NAME: | prosthesis, toe (metatarso-phalangeal), joint,
metal/polymer, semi-constrained |
| CLASSIFICATION: | unclassified |
| PRODUCT CODE: | LZJ |
| PANEL: | Orthopedic |
| PREDICATE DEVICES: | KGTI™ Kinetik Great Toe Implant System,
Integra Lifesciences, K924724 |
| | Merete ToeMobile™ Anatomical Great Toe
Resurfacing System, Merete Medical,
K072251 |
| DEVICE DESCRIPTION: | The Ascension® MOVEMENT Great Toe
System, Total Arthroplasty device is an
anatomically designed, semi-constrained,
two-piece device designed for resurfacing of
the base of the 1st metatarso-phalangeal
(MTP) joint. The device couples with the
Ascension metatarsal hemi-arthroplasty
device to allow total arthroplasty of the 1st
MTP joint. The device is designed for
cemented fixation. The device is boxed
individually and delivered sterile for single
use. The device incorporates four
anatomically designed base geometries with
appropriately sized stems. The stem is
cylindrical with tapered ribs to provide
rotational as well as axial stability of the
seated implant. System instrumentation is
designed to offer precise implant preparation. |
.
1
77
INTENDED USE:
The Ascension® MOVEMENT™ Great Toe System, Total Arthroplasty is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal ioint (MTP). The device is intended for cemented use only. Indications for use include:
- . Painful degenerative metatarsophalangeal joint change
- . Hallux rigidus stage 3 and 4
- . Hallux valqus and hallux rigidus
- . Hallux limitus with painful arthrofibrosis
- . Revisions after moderate proximal phalanx resection
Substantial equivalence was based upon testing and a geometrical comparison of the subject and predicate devices. Interconnection strength testing, axial, shear and bending strength, was performed to substantiate equivalence. Geometrical comparisons between the subject device, Ascension® MOVEMENT™ Great Toe System and Integra KGTI™ Kinetik Great Toe Implant System (K904724) were completed. The Merete ToeMobile Anatomical Great Toe Resurfacing System (K072251) was used as a template for labeled indications.
There are no significant differences between the Ascension MOVEMENT 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.
BASIS OF SUBSTANTIAL EQUIVALENCE:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
DEC 2 1 , 2010
Ascension Orthopedics, Inc. % Ms. Susan Walton 8700 Cameron Road, #100 Austin, TX 78754-3832
Re: K102549
Trade/Device Name: Ascension MOVEMENT Great Toe System Regulation Number: Unclassified Regulation Name: Prosthesis, Toe (metatarso-phalangeal), Joint, Metal/polymer, Semiconstrained Regulatory Class: Unclassified Product Code: LZJ Dated: December 9, 2010 Received: December 10, 2010
Dear Ms. Walton:
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. Susan Walton
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 go to http://www.fda.gov/AboutFDA/CentersOffices/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/Reportal?roblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
AC. B. 2. h
Din
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(K) Number.
Kj02549
Device Name:
Ascension® MOVEMENT™ Great Toe System
Indications for Use:
The Ascension® MOVEMENT™ Great Toe System, Total Arthroplasty is a twopiece implant that is intended to be used as prosthesis for the metatarsophalangeal joint (MTP). The device is intended for cemented use only. Indications for use include:
- Painful degenerative metatarso-phalangeal joint change .
- Hallux rigidus stage 3 and 4 ◆
- Hallux valgus and hallux rigidus .
- Hallux limitus with painful arthrofibrosis .
- Revisions after moderate proximal phalanx resection .
Prescription Use x (Part 21 CFR 801Subpart B)
OR
Over-The-Counter Use (Part 21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. Melkerson
Division Sign Off
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K102549