(67 days)
Not Found
No
The summary describes a mechanical implant (a staple) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an implantable staple for bone fixation, which is a structural device rather than one that treats or prevents disease/conditions through physiological means.
No
Explanation: The NexFix™ Compression Staple is a surgical implant used for fixation of fractures, fusions, and osteotomies, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is made of Stainless Steel and is intended to be implanted, indicating it is a physical hardware device, not software.
Based on the provided information, the NexFix™ Compression Staple 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, tissue) to provide information about a person's health.
- NexFix™ Function: The NexFix™ Compression Staple is an implantable device made of stainless steel. Its purpose is to physically fix fractures, fusions, and osteotomies in bones. It is used within the body, not to test samples from the body.
- Intended Use: The intended use clearly states "fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot." This describes a surgical intervention, not a diagnostic test.
Therefore, the NexFix™ Compression Staple falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The NexFix™ Compression Staple is indicated for fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot.
Product codes
87 JDR
Device Description
The Nexa Orthopedics NexFix™ Compression Staple is made of Stainless Steel intended to be implanted into the bones of the fore foot, mid foot and hind foot. The stables are provided in 21 sizes. The staples are used for fracture fixation, fusion, and osteotomy of the bones of the hand and foot.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, fore foot, mid foot and hind foot
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
Non-Clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the device was functional within its intended use. Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K043059 Wright Medical Compression Staple and simple staple, K011716 New Deal UniClip Staple, K060014 Intelifuse Warmsystem with StimuLinks
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510 (k) Summary
| Prepared: | March 8, 2007 |
|---|---|
| Applicant: | Nexa Orthopedics, Inc. |
| 11035 Roselle Street | |
| San Diego, CA 92121 | |
| Contact: | Louise M. Focht |
| Device Name: | Nexa Staple |
| Device Trade Name: | NexFix™ Compression Staple |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 21 CFR 888.3030 Single/multiple |
| component metallic bone fixation | |
| appliances and accessories. | |
| Product Code: | 87 JDR |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9028319 |
R070688
MAY 18 2007
Legally marketed device to which substantial equivalence is claimed:
The legally marketed devices to which substantial equivalence is claimed are the K043059 Wright Medical Compression Staple and simple staple, K011716 New Deal UniClip Staple, and K060014 Intelifuse Warmsystem with StimuLinks
Device Description:
The Nexa Orthopedics NexFix™ Compression Staple is made of Stainless Steel intended to be implanted into the bones of the fore foot, mid foot and hind foot. The stables are provided in 21 sizes. The staples are used for fracture fixation, fusion, and osteotomy of the bones of the hand and foot.
Intended Use:
The Nexa Staple is indicated for fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot.
Summary of Technologies:
The device and the predicate devices have similar design characteristics and intended use. Information provided in the application demonstrates the Nexa device is substantially equivalent to the predicate device.
Non-Clinical Testing: Non-Clinical laboratory testing was performed to determine substantial equivalence. The results indicate that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nexa Orthopedics, Inc % Ms. Louise M. Focht 11035 Roselle St. San Diego, California 92121
MAY 1 8 2007
Re: K070688
Trade/Device Name: NexFix™ Compression Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: March 8, 2007 Received: March 13, 2007
Dear Ms. Focht:
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.
2
Page 2 - Ms. Louise M. Focht
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 Office of 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Karvare bouchn
Mark N. Melkerson 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): Ko7068
Device Name: NexFix™ Compression Staple
Indications for Use:
The NexFix™ Compression Staple is indicated for fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Seubere Brient
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K670688