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.

AI/ML Overview

The provided document is a 510(k) summary for the Nexa Orthopedics NexFix™ Compression Staple. It states that no clinical testing was performed as a basis for substantial equivalence. Therefore, there are no acceptance criteria, device performance data, or studies that prove the device meets acceptance criteria as typically found in clinical trials.

The substantial equivalence was based on non-clinical laboratory testing and the device having similar design characteristics and intended use to legally marketed predicate devices.

Here's a breakdown based on the information provided, highlighting the absence of clinical study details:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission states "Clinical Testing: None provided as a basis for substantial equivalence." The non-clinical testing results "indicate that the device was functional within its intended use," but specific acceptance criteria and detailed performance metrics from these tests are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set was used for substantial equivalence. For non-clinical testing, the sample size and data provenance are not specified in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. No clinical test set requiring expert-established ground truth was used for substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication was performed for substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical medical implant (compression staple), not a software algorithm, so the concept of standalone algorithmic performance is irrelevant.

7. Type of Ground Truth Used

Not applicable for clinical studies. For the non-clinical testing that was performed, the "ground truth" would be engineering specifications and mechanical testing standards, but the specific details are not provided in this summary.

8. Sample Size for the Training Set

Not applicable. No training set was used as no clinical study or algorithm development was detailed for this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

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510 (k) Summary

Prepared:	March 8, 2007
Applicant:	Nexa Orthopedics, Inc.11035 Roselle StreetSan 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/multiplecomponent metallic bone fixationappliances 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:

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.

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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.

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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

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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

Regulation Number and Section

§ 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.