(44 days)
Not Found
No
The 510(k) summary describes a purely mechanical implant for bone fixation and makes no mention of AI, ML, or any software-driven features.
No
The device is described as an implant for the fixation of bone fractures, bone reconstruction, osteotomy, or arthrodesis, which are structural and mechanical functions, not therapeutic.
No
The device, the NexFix™ Compression Pin, is described as an implant for the fixation of bone fractures, bone reconstruction, osteotomy, or arthrodesis. Its function is to provide structural support and aid in healing, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a one-piece implant made of Stainless Steel or Titanium Alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- NexFix™ Compression Pin Function: The NexFix™ Compression Pin is an implantable device used for the mechanical fixation of bone fractures, reconstruction, osteotomy, and arthrodesis. It is physically placed inside the body to stabilize bone.
The description clearly indicates a surgical implant for structural support, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The NexFix™ Compression Pin is intended to be implanted for the fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.
Product codes (comma separated list FDA assigned to the subject device)
87 JDW
Device Description
The Nexa Orthopedics, Inc Implant is a one-piece device made of Stainless Steel or Titanium Alloy, intended for fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis. The implant is designed in 10 sizes. The device is tapered and threaded on the leading end and smooth on the trailing end. The implant is used in the treatment of bone fractures or bone reconstruction, including osteotomy, and joint fusion. The design of the NexFix™ Compression Pin is similar to the predicate devices. No new materials or processes are used in the development of this implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot and ankle and hand and wrist
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary as required by section 807.92(c)
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
| Prepared: | September 24, 2007 |
|---|---|
| Applicant: | Nexa Orthopedics, Inc |
| a Tornier Company | |
| 11035 Roselle Street | |
| San Diego, CA 92121 | |
| Telephone: | 858-866-0660 × 155 |
| Fax: | 858-866-0661 |
| Contact: | Corey Wilson-Wirth |
| Common Name: | Threaded pin |
| Device Trade Name: | NexFix™ Compression Pin |
| Device Classification Name: | Smooth or threaded metallic bone fixation |
| fastener | |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number: | 888.3040 |
| Product Code: | 87 JDW |
| Predicate Device: | K051740, Tapered Compression Pin |
| Futura Biomedical | |
| K993910 TAC Pin, Newdeal | |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9100540 |
Device Description:
The Nexa Orthopedics, Inc Implant is a one-piece device made of Stainless Steel or Titanium Alloy, intended for fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis. The implant is designed in 10 sizes. The device is tapered and threaded on the leading end and smooth on the trailing end. The implant is used in the treatment of bone fractures or bone reconstruction, including osteotomy, and joint fusion. The design of the NexFix™ Compression Pin is similar to the predicate devices. No new materials or processes are used in the development of this implant.
Indications for Use:
The NexFix™ Compression Pin is intended to be implanted for the fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.
1
Comparison to Predicate Device:
Similarities of the NexFix Compression Pin to its predicates include these devices being: intended for single use only, intended for surgical implantation longer than 30 days, system consisting of a series of pins or various diameters and thread lengths, made of industry standard materials, with no new materials being introduced in the product, comparably sized, and indicated for the same uses.
Summary:
The device and the predicate device have the same design characteristics and intended use. The new device is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 8 2007
Nexa Orthopedics, Inc. a Tornier Company % Mr. Corey Wilson-Wirth 11035 Roselle Street San Diego. CA 92121
Re: K072710
Trade/Device Name: NexFix™ Compression Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: September 24, 2007 Received: September 25, 2007
Dear Mr. Wilson-Wirth:
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 - Mr. Corey Wilson-Wirth
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Varbara Buelup
Jos
Mark N. Melk 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): K072710 Device Name: NexFix™ Compression Pin Indications for Use:
The NexFix™ Compression Pin is intended to be implanted for the fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
farbare Brien
Offision Sign-(Division Signeral, Restorative, Division
and Neurological Devices
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510(k) Number.