(50 days)
No
The 510(k) summary describes a mechanical orthopedic implant (an ankle nail) and its intended uses. There is no mention of software, algorithms, image processing, AI, or ML in the device description, intended use, or performance summary. The device appears to be purely mechanical.
No
The device is an intramedullary nail used for orthopedic surgical procedures, acting as an implant to stabilize bones, rather than a therapeutic device that delivers treatment or therapy.
No
Explanation: The Newdeal Ankle Nail is an intramedullary nail used for tibiotalocalcaneal arthrodesis and treatment of trauma. It is a surgical implant, not a device that diagnoses a condition.
No
The device description clearly describes a physical intramedullary nail made of Ti-6Al-4V ELI alloy, along with locking screws and an end cap. This is a hardware device, not software.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text describes a surgical implant (an intramedullary nail) used to stabilize bones in the ankle and lower leg for arthrodesis (fusion) and trauma treatment. It is a physical device implanted within the body.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples or provide diagnostic information. Its function is purely mechanical and structural.
Therefore, based on the provided information, the Newdeal Ankle Nail is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:
- Post-traumatic and degenerative arthritis involving both ankle and subtalar ioints
- rheumatoid arthritis -
- revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
- revision of failed total ankle arthroplasty with subtalar intrusion ー
- talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) -
- avascular necrosis of the talus -
- Neuroarthropathy or neuropathic ankle deformity ー
- severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- severe pilon fractures with trauma to the subtalar joint -
Product codes
HSB
Device Description
The Newdeal Ankle Nail is a straight, cannulated intramedullary nailable in The Newcal 11mm, 12mm and 13mm, and lengths of 150mm and 180mm. dialiciers of 11 mm, TEMP proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long by 5mm increment. Screws Shim anameter, the end cap and the locking screws are all made from Ti-6Al-4V ELI alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hindfoot and distal tibia
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
Sunninary of Statures Ankle Nail meets our acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KOSO882
Image /page/0/Picture/1 description: The image shows the logo for Newdeal, an Integra LifeSciences Company. The logo features the word "newdeal" in a bold, sans-serif font, with the "®" symbol next to it. To the left of the word is a circle with five dots around it, one of which is shaded gray.
MAY 2 7 2005
510(k) SUMMARY
Applicant's Name and Address: A.
Newdeal SA Newaterra LifeSciences Company 10, place d'Helvétie 69006 LYON FRANCE Tel.: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52 ESTABLISHMENT REGISTRATION NUMBER: 9615741
Authorized Agent and Official Contact Person: B.
Judith O'Grady Sr. VP Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 USA TEL: 609-936-2311 FAX: 609-275-9445
- Date Summary Prepared: C. April 6, 2005
- Name of Device: D. Proprietary Name: Newdeal Ankle Nail
Common Name: Ankle nail
Classification Name and Reference: Intramedullary fixation rod (21 CFR 888.3020)
Device Product Code: HSB
Proposed Regulatory Class: Class II
Panel: Orthopedic
- Device Description E.
Device Description
The Newdeal Ankle Nail is a straight, cannulated intramedullary nailable in The Newcal 11mm, 12mm and 13mm, and lengths of 150mm and 180mm. dialiciers of 11 mm, TEMP proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long by 5mm increment. Screws Shim anameter, the end cap and the locking screws are all made from Ti-6Al-4V ELI alloy.
1
The Newdeal Ankle Nail is to be implanted by insertion through the calcaneus, the The Newton Ankie Fran is to to otalocalcaneal arthrodesis, for correction of deformity, or fixation of fractures.
Indications for Use F.
Indications for USC
The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and The Newtrair Annue Nair nindfoot and distal tibia. Examples include:
- liment of traumatic and degenerative arthritis involving both ankle and subtalar joints
- Rheumatoid arthritis -
- Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
- nisurioient tailer total ankle arthroplasty with subtalar intrusion -
- Revision of faired total ons (requiring a tibiocalcaneal arthrodesis) -
- Avascular necrosis of the talus -
- Neuroarthropathy or neuropathic ankle deformity -
- Newroalthropatity of nearspants. Inclipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- pararyons or ofractures with trauma to the subtalar joint -
Substantial Equivalence G.
Substantial Equivalence indications for use and dimensions with the following predicate devices:
| Smith & Nephew | ReVision Nail | K983942 |
|---|---|---|
| DePuy | VersaNail | K023115 |
| Biomet | Ankle Arthrodesis Nail | K021786 |
Comparison of Technological Characteristics H.
Comparison of 1 cennotogical Onf the Newdeal Ankle Nail are the same as the The technological charges in terms of intended use and design. All of these nails have the following characteristics:
- Holed for proximal and distal locking -
- Made from Titanium alloy or stainless steel -
- Cannulated -
- Equivalent size range -
- Intended to be implanted for tibiocalcaneal arthrodesis -
Summary of Studies I.
Sunninary of Statures Ankle Nail meets our acceptance criteria.
J. Conclusion
Conclusion & Nephew ReVision nail, K983942, DePuy ACE VersaNail, K023115 and Biomet Ankle Arthrodesis Nail, K021786.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
MAY 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Newdeal SA C/o Ms. Judith E. O'Grady Senior V.P Regulatory Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K050882
Trade/Device Name: Newdeal Ankle Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: April 6, 2005 Received: April 7, 2005
Dear Ms. O'Grady:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Judith E. O'Grady
This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and in your of substantial equivalence of your device of your device to a legally marketed predicate device results in a classification 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 dealer specific and Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Ecterers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Miriam C. Provost, Ph.D.
m C. Provost. Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: NEWDEAL ANKLE NAIL
Indications For Use:
The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:
- Post-traumatic and degenerative arthritis involving both ankle and subtalar ioints
- rheumatoid arthritis -
- revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
- revision of failed total ankle arthroplasty with subtalar intrusion ー
- talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) -
- avascular necrosis of the talus -
- Neuroarthropathy or neuropathic ankle deformity ー
- severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- severe pilon fractures with trauma to the subtalar joint -
Prescription Use X (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 IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division Sign-Off) | |
| Division of General, | |
| and Neurological Devices |
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5110(1) Number K050882