(127 days)
Not Found
No
The summary describes a physical implant made of silicone elastomer and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for hammertoe deformities associated with degenerative or rheumatoid arthritis, and for revision of failed arthroplasty or arthrodesis, which are therapeutic uses.
No
Explanation: The device description clearly states it is an implant designed for the proximal interphalangeal joint, and its intended use is to treat hammertoe deformities, not to diagnose them.
No
The device description explicitly states it is a "double-stemmed flexible implant" made of "silicone elastomer," which are physical materials and components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The OrthoFlex Rod is a physical implant designed to be surgically placed within the body (specifically, the proximal interphalangeal joint of the lateral toes).
- Intended Use: The intended use is to treat hammertoe deformities by providing structural support and flexibility within the joint. This is a therapeutic intervention, not a diagnostic test.
The description clearly indicates a surgically implanted device used for treatment, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The indications for the OrthoFlex Rod include:
- t Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis
- . Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis
- . Revision of a failed arthroplasty or arthrodesis
Product codes (comma separated list FDA assigned to the subject device)
KWH
Device Description
The OrthoFlex Rod design is a double-stemmed flexible implant designed for the proximal interphalangeal joint of the lateral toes. It is made of silicone elastomer, and is constructed in a rod-shaped design with a thicker mid-section spacer or collar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal interphalangeal joint of the lateral toes
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)
No clinical studies were performed
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.
K022886/ K022887, K905795, K801094
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
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.
0
510(k) Summarv for the OrthoFlex Rod
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the OrthoFlex Rod
JAN 1 4 2011
Date Prepared: January 4, 2011
- Submitter: 1. OrthoPro LLC 3450 Highland Drive, Ste 303 Salt Lake City, UT 84106
Contact Person: J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
- Trade name: OrthoFlex Rod Common Name: silicone toe prostheses Classification Name: prosthesis, toe, constrained, polymer 21CFR 888.3720 KWH Class II
3. Predicate or legally marketed devices which are substantially equivalent:
- . Metatarsophalangeal and Interphalangeal - K022886/ K022887 (OsteoMed)
- . Shaw-Ship Rod - K905795 (Sgarlato Laboratories)
- . Swanson Hammertoe Implant - K801094 (Wright Medical Technology)
4. Description of the device:
The OrthoFlex Rod design is a double-stemmed flexible implant designed for the proximal interphalangeal joint of the lateral toes. It is made of silicone elastomer, and is constructed in a rod-shaped design with a thicker mid-section spacer or collar.
5. Substantial equivalence claimed to predicate devices
OrthoFlex Rod is substantially equivalent to the OsteoMed, Sgarlato Laboratories and Wright Medical Technology devices in terms of intended use, design, and materials used.
6. Intended Use:
The indications for the OrthoFlex Rod include:
- t Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis
- . Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis
- . Revision of a failed arthroplasty or arthrodesis
7. Clinical Test Summary
No clinical studies were performed
8. Conclusions Nonclinical and Clinical
OrthoFlex Rod is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OrthoPro LLC % The OrthoMedix Group, Inc. Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock. Texas 78681.
JAN 1 4 2011
Re: K102601
Trade/Device Name: Ortholilex Rod Regulation Number: 21 CFR 888.3720 Regulation Name: Toe joint polymer constrained prosthesis Regulatory Class: Class II Product Code: KWH Dated: January 05, 2011 Received: January 11, 2011
Dear Mr. Wcbb:
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
2
Page 2 - Mr. J. D. Webb
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _
Device Name: OrthoFlex Rod
Indications for Use:
The indications for the OrthoFlex Rod include:
- 트 Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis
- Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis 이
- . Revision of a failed arthroplasty or arthrodesis
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Meukerm
(Division Sign-Oft) Division of Surgical, On hopedic, and Restorative Devices
K10 2609
510(k) Number