(44 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical implant (nail) and accessories for ankle arthrodesis. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical strength, which is typical for orthopedic implants.
Yes
The device is intended for arthrodesis (fusion) and stabilization of the hindfoot and ankle, addressing various medical conditions like arthrosis, failed joint replacements, and deformities, which directly treat or manage a disease or condition.
No
Explanation: The device is an arthrodesis nail used for fusion and stabilization, which is a therapeutic treatment. It is not used to identify or diagnose a condition.
No
The device description clearly states it is an "Ankle Arthrodesis Nail" and describes its physical characteristics and intended use in surgical procedures, indicating it is a physical implant and associated accessories, not software.
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 (an ankle arthrodesis nail) used for fusing bones in the ankle and hindfoot. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description confirms it's a physical implant (nail) and accessories used in a surgical procedure.
- 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
The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
- . Post-traumatic or primary Arthrosis
- . Previously infected arthrosis (second degree)
- Revision of Failed Ankle Arthrodesis .
- . Failed Total Ankic Replacement
- . Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis)
- . Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle
- . Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot
- . Ostheoartritis
- . Nonunions or Pseudarthrosis of hindfoot and distal tibia
- . Malunited tibial pilon fracture
- . Charcot foot
- t Severe endstage degenerative arthritis
- Severe defects after tumor resection .
- . Pantalar arthrodesis
Product codes (comma separated list FDA assigned to the subject device)
87 HSB
Device Description
This 5 10(k) submission is a line extension to the T2® Nailing System to add an ankle arthrodesis nail and additional accessories to the system. The nails are inserted using an opened or closed technique and can be locked in static, dynamic or compression mode. The T2® Ankle Nails and accessories are intended for sungle use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot, tibiotalocalcaneal
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)
Testing demonstrated comparable mechanical strength 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.
Not Found
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
JUL 2 9 2005
K051590 510(k) Summary of Safety and Effectiveness: T2® Ankle Arthrodesis Nail
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430 |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5581
Fax: (201) 831-6038 |
| Date Summary Prepared: | July 25, 2005 |
| Device Identification | |
| Proprietary Name: | T2® Ankle Arthrodesis Nail |
| Common Name: | Intramedullary Nail |
| Classification Name and Reference: | Intramedullary Fixation Rod and Accessories, 21 CFR §888.3020 |
| Device Product Code | 87 HSB |
Description:
This 5 10(k) submission is a line extension to the T2® Nailing System to add an ankle arthrodesis nail and additional accessories to the system. The nails are inserted using an opened or closed technique and can be locked in static, dynamic or compression mode. The T2® Ankle Nails and accessories are intended for sungle use only.
Intended Use:
The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
- . Post-traumatic or primary Arthrosis
- . Previously infected arthrosis (second degree)
- Revision of Failed Ankle Arthrodesis .
- . Failed Total Ankic Replacement
- . Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis)
- . Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle
- . Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot
- . Ostheoartritis
- . Nonunions or Pseudarthrosis of hindfoot and distal tibia
- . Malunited tibial pilon fracture
- . Charcot foot
- t Severe endstage degenerative arthritis
- Severe defects after tumor resection .
- . Pantalar arthrodesis
Substantial Equivalence:
The T2® Ankle Arthrodesis Nail is substantially equivalent to other legally marketed ankle nails in regards to design, materials, indications and operational principles. Testing demonstrated comparable mechanical strength to the predicate devices.
13
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's symbol, which consists of a stylized human figure with three arms extending upwards. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is written around the perimeter of the circle.
JUL 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vivian Kelly, RAC Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K051590
Trade/Device Name: T2® Ankle Arthrodesis Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: June 14, 2005 Received: June 15, 2005
Dear Ms. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(t) premainer is substantially equivalent (for the indications referenced above and nave ucterinined we arredicate devices marketed in interstate for use stated in the encrosure, to regars mannent date of the Medical Device American on to commence prior to May 20, 1776, the exactiance with the provisions of the Federal Food, Drug, devices that have been reclassified in acceraanse was now has he proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The You may, therefore, market the device, busyer to the mail registration, listing of general controls provisions of the fiel her in and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FD may be subject to such additional controller Life 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I same oncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease oe advised that I Dri 3 issuation of a complies with other requirements of the Act inal IDA has made a dolorimation an administered by other Federal agencies. You must or any receral statutes and regulations and admited to: registration and listing (21 comply with an the Not 3 requirements, 01); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Ms. Vivian Kelly, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket nothcation. The PDA miding of bassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice ion your access at (240) 276-0120. Also, please mote the regulation entitled, program and contact the Office of Comphane as (21 ) 11 (21 Part 807.97). You may obtain "Misoranting by relevelee to premainter for the Act from the Division of Small other general information on your responsible in the toll-free number (800) 638-2041 or Manufacturers, Internet and Corses http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K051590
Device Name: T2® Ankle Arthrodesis Nail
Indications for Use:
The T2® Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to The T2" Ankle Arthrodesis Nail is mlended to thought the userse tarsal joints coupling the provide stabilization of the mind of specific indications include:
- Post-traumatic or primary Arthrosis .
- Previously infected arthrosis (second degree) .
- Revision of Failed Ankle Arthrodesis .
- Failed Total Ankle Replacement .
- Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis) .
- Availar Processes or Neuromuscular Deformity or other neuromuscular disease with severe deformity . or instability of the ankle
- Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot .
- Ostheoartritis .
- Nonunions or Pseudarthrosis of hindfoot and distal tibia .
- Malunited tibial pilon fracture .
- Charcot foot .
- Severe endstage degenerative arthritis .
- Severe defects after tumor resection .
- Pantalar arthrodesis .
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (Part 21 CPR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
CONTINUE ON AND WRITE BELOW THIS LINEFERS NEEDED)
Concurrence of CPRH, Office of Device Evaluation (ODE)
Page 1 of 1
ence of CDRH, Office of Device Evaluation
(Division Sign-Off) Division of General, Restorative, and - crological Devices
1190 510(k) Number_