1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of the implant upon the healing of growth plate has not been tested clinically.

Device Description

The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000)
Lengths of implants are 14, 16, 18, 20 and 25 mm. -
Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) and -1.5mm Bone Fixation Kit (K012000)
Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000). -
Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.

The modifications are:

Amendment of new length, 14mm implant, into product line. -
Modified design accordingly. -

AI/ML Overview

The provided 510(k) summary does not contain the detailed information typically associated with acceptance criteria and a study that proves a device meets those criteria, especially for a software-based medical device.

This submission is for a physical medical device: the 1.5mm Bone Fixation Kit, an absorbable bone fixation nail. For such devices, "acceptance criteria" and "study" would typically refer to mechanical and material testing, and possibly pre-clinical (animal) or limited clinical trials (human) demonstrating safety and performance. However, this submission focuses on demonstrating substantial equivalence to existing predicate devices rather than providing detailed study results.

Here's a breakdown based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

The submission does not provide a table of acceptance criteria or reported device performance in the way a software or AI device submission would. Instead, it relies on demonstrating that the revised device (with a new length and minor design modification) is substantially equivalent to existing cleared devices.

The key performance aspect mentioned is:

"This modification has no effect on pull-out properties of the device."
- This is a critical mechanical property for bone fixation devices, implying that testing was conducted to ensure the pull-out strength of the modified device remained comparable to the predicate. However, no specific values, criteria, or test results are provided in this summary.

2. Sample sized used for the test set and the data provenance

Sample Size: Not mentioned. It's likely that mechanical and material testing involved a certain number of implants, but this detail is not in the summary.
Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to a physical bone fixation device. "Ground truth" in this context would be established through engineering and material testing standards.

4. Adjudication method for the test set

This is not applicable to
a physical bone fixation device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as the device is a physical bone fixation implant, not a diagnostic or AI-assisted device for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical bone fixation implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, "ground truth" would be established through recognized engineering standards for mechanical strength (e.g., pull-out strength, bending strength), material biocompatibility, and degradation rates. The submission states the device uses the "very same raw material" as predicates, implying material properties are consistent. Specific details of these tests and their results are not included in the summary.

8. The sample size for the training set

This question is not applicable as the device is a physical bone fixation implant. There is no AI or machine learning component requiring a training set.

9. How the ground truth for the training set was established

This question is not applicable as the device is a physical bone fixation implant.

Summary of Device Performance (Based only on the provided text):

The device performance is inferred from its substantial equivalence claim, specifically:

The material (poly-L/D-lactide copolymer) is identical to predicate devices.
The diameter (1.5mm) is identical to predicate devices.
The shelf life is identical to predicate devices.
Crucially, the submission explicitly states: "This modification has no effect on pull-out properties of the device." This implies that testing was conducted to confirm this, and the device performs equivalently to the predicates in terms of its ability to fix bone fragments without prematurely dislodging.

Missing Information:

The 510(k) summary provided here is a high-level overview focused on substantial equivalence. It lacks the specific details of mechanical testing methodologies, quantitative acceptance criteria (e.g., minimum pull-out strength in Newtons), and the actual test results that would typically be reviewed by the FDA as part of the full submission for a physical device. These details are generally found in the comprehensive testing reports within the complete 510(k) submission, not typically in the public-facing summary document.

Summary

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510(k) Summary NOV 21 2001 Bionx Implants Inc. 1.5mm Bone Fixation Kit

Submitter's Name, Address, Telephone Number, and Contact Person

Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Blue Bell, PA 19422

Gerard S. Carlozzi Contacts: President and CEO Phone: (215) 643-5000 Facsimile: (215) 653-0984

Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland, Europe 358-3-316 5600 Phone: 358-3-316 5629 Facsimile:

October 9th, 2001 Date prepared:

Name of the device:

A.	Trade or Proprietary Name: 1.5mm Bone Fixation Kit
B.	Common Name:	Absorbable Bone Fixation Nail
C.	Classification Name:	Bone Fixation Nail
D.	Device Product Code:	MAI and HWC

Predicate Device:

1. Bionx Implants, Inc. SmartNail (K993074)
1. Bionx Implants, Inc. 1.5mm Bone Fixation Kit (K012000)

Intended Use:

Properly used, in the presence of adequate immobilization, 1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

ﺴﺴ

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Device Description:

The device description of the 1.5mm Bone Fixation Kit is as follows.

The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000)
Lengths of implants are 14, 16, 18, 20 and 25 mm. -
Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) and -1.5mm Bone Fixation Kit (K012000)
Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000). -
Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.

The modifications are:

Amendment of new length, 14mm implant, into product line. -
Modified design accordingly. -

Substantial Equivalence:

Bionx Implants Inc. 1.5mm Bone Fixation Kit is substantially equivalent to the cleared Bionx Implants Inc. SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000). This amendment of one new length with little change in design does not raise any new concerns of safety and efficacy of the implant. This modification has no effect on pull-out properties of the device.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three birds in flight, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2001

Mrs. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants, Ltd. Hermiankatu 6-8 L Tampere, Finland

Re: K013546

Trade/Device Name: 1.5mm Bone Fixation Kit Regulation Number: 21 CFR §888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC and MAI Dated: October 8, 2001 Received: October 24, 2001

Dear Mrs. Annala:

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 for abouted in the 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 - Mrs. Tuija Annala

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Millenson

Celia M. Witten, Ph.D., M.D. 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): KO13546

NOV 21 2001

1.5mm Bone Fixation Kit Device Name:

Indications for Use:

1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of 1.5mm Bone Fixation Kit upon the healing of growth plate has not been tested clinically.

(Please do not write below this line - continue on another page is needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

(Per 21 CFR 801.109)

OR Over-The-Counter Use

Regulation Number and Section

§ 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.