ReFIX Biodegradable Pins are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

For example, ReFIX pins are intended for use in the following procedures:

fixation of phalangeal fusion and fracture .
repair of metacarpal fusion and fracture
fixation of hand and wrist fractures .
fixation of metatarsal osteotomies .
correction of hallux valgus .

Device Description

Brief Description of Internal Fracture Fixation Devices based upon ReFIX™ Pins are comprised of themal Package Pakken Divers are widely used in the orthopaedic specialty. The ReFTX Pins are manufactured from PLLA and PLGA. The pins are available in diameters of 2.0mm, 2.7mm, 3.5mm, and 4.5mm, each supplied in a length of 70mm. The pins are sized and trimmed intraction and materials are de length of 70mm. The pins are sized and unimited misues and materials are designed to address the indications cited.

AI/ML Overview

This 510(k) premarket notification for the ReFIX™ Internal Fixation Pins does not involve a study to prove the device meets acceptance criteria in the context of AI/ML performance. Instead, it demonstrates substantial equivalence to previously marketed devices. Therefore, most of the requested information about acceptance criteria, study design, and performance metrics for AI/ML devices is not applicable.

Here's the information that can be extracted from the provided document, framed within the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a traditional medical device (fixation pins), there are no explicit "acceptance criteria" for AI/ML performance or specific device performance metrics reported in the way they would be for an AI-powered diagnostic or therapeutic device. The "acceptance criteria" here are met by demonstrating equivalence to predicate devices, focusing on the device's fundamental characteristics and intended use.

Acceptance Criteria (Demonstrated Equivalence Feature)	Reported Device Performance (Reference to Predicate Device Features)
Intended Use	Intended for use in fixation and/or alignment of fragments of fractured non-load bearing bones, osteochondral fragments, and cancellous/non-load bearing fragments. Also for phalangeal fusion & fracture, metacarpal fusion & fracture, hand & wrist fractures, metatarsal osteotomies, and hallux valgus correction.
Material	Manufactured from PLLA and PLGA, similar to predicate devices (e.g., K010983 - PLLA Pin, K003659 - PLGA Pin).
Operational Principles	Functions as an internal fixation device for bone fragments, consistent with the operational principles of predicate devices.
Design (Dimensions)	Available in diameters of 2.0mm, 2.7mm, 3.5mm, and 4.5mm, and a length of 70mm, within the typical range for similar devices.

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

Not applicable. This is not an AI/ML study involving a "test set" of data for performance evaluation. The "test" is the comparison against predicate devices through documentation and engineering analysis.

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

Not applicable. No ground truth was established by experts for a test set in the context of AI/ML performance. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices based on their prior 510(k) clearances.

4. Adjudication Method for the Test Set

Not applicable. There was no test set or adjudication process for AI/ML performance.

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

Not applicable. This is not an AI-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm-only device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices. The submission relies on the concept that if the new device is substantially equivalent in terms of intended use, technological characteristics (materials, design), and operational principles to existing cleared devices, then it can also be considered safe and effective.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML training set.

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

Not applicable. There is no AI/ML training set.

Summary of the Document's Focus:

The provided document describes a 510(k) premarket notification for the ReFIX™ Internal Fixation Pins, a biodegradable internal fixation device. The basis for its clearance is substantial equivalence to a list of previously cleared predicate devices. This means that instead of conducting a new clinical trial or performance study, the manufacturer demonstrates that their device is as safe and effective as existing legally marketed devices, based on similar intended use, materials (PLLA and PLGA), and operational principles.

Summary

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APR 1 8 2005

510(K) SUMMARY

page 1 of 2

Subject 510(k) Number - K0433339

Sponsor

Xtremi-T, LLC

3131 Princeton Pike Bldg 5, Suite 200 Lawrenceville, New Jersey 08648

FDA Establishment Registration Number

3004613836

Official Contact

Shawn T. Huxel, President Xtremi-T, LLC 3131 Princeton Pike; Bldg 5, Suite 200 Lawrenceville, New Jersey 08648 Phone - (609) 896-0008 Fax - (908) 842-0310 Mobile - (908) 896-5893

Proprietary Name

ReFIX™ Internal Fixation Pins

Common Name

Biodegradable Internal Fixation Device

Classification Name and Reference

888.3040 -- Smooth or Threaded Bone Fixation Fastener

Regulatory Class Class II

Device Product Code (Panel 87) HTY

Date Prepared 14 March, 2005

Xtremi-T, LLC

Confidential

Pg 14 of 112

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K043339
Page 2 of 2

Brief Description of Device

Brief Desoription of Internal Fracture Fixation Devices based upon ReFIX":" Pins are comprised of themal Package Pakken Divers are widely used in the orthopaedic specialty. The ReFTX Pins are manufactured from PLLA and PLGA. The
orthopaedic specialty. The ReFTX Pins are manufactured from exch supplied i orthopaedic specialty. The ReFTX Phis are niamatacanon and 4.5mm, each supplied in a
pins are available in diameters of 2.0mm, 2.7mm, 3.5mm, and 4.5mm, the ReFIX pins are available in diameters of 2.0mm, 2.7mm, Stance, atively using the ReFIX
length of 70mm. The pins are sized and trimmed intraction and materials are de length of 70mm. The pins are sized and unimited misues and materials are designed to address the indications cited.

Indications for Use

midications for USC ReFIX Biodegradable Pins are intended to use in and arthrodeses; and fixation
fragments of fractured non-load bearing bones, osted broads and fixation fragments of fractured non-load ocaring bones, osteochondral fragments and cancellous/non-load bearing fragments.

For example, ReFIX pins are intended for use in the following procedures:

fixation of phalangeal fusion and fracture .
repair of metacarpal fusion and fracture t
fixation of hand and wrist fractures .
fixation of metatarsal osteotomies .
correction of hallux valgus ●

Basis for Substantial Equivalence

Dasis for Oubstantial equivalence of the ReFIX Pins is based on the equivalence in intended I no substantial verational principals, and indications to:

DEVICE	Manufacturer	Trade Name
K010983	Bionx	PLLA Pin
K003659	Bionx	PLGA Pin
K925098	Bionx	Biofix Pin
K031712	Inion	OTPS Pin
K040500	Biomet	Lactonail
K011522	Biomet	Resorbable Bone Pins
K990291	Biomet	Lactosorb Bone Pin
K953194	Biomet	Lactosorb Bone Pin
K890902	D&G	Biofix Pin
K901456	J&J	Orthosorb
K864912	J&J	PDS Pin

END OF 510(K) SUMMARY

Xtremi-T, LLC

Pg 15 of 112

Confidential

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.

APR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Shawn T. Huxel President, GM Xtremi-T, LLC 3131 Princeton Pike Building 5, Suite 200 Lawrenceville, New Jersey 08648

Re: K043339

K043339
Trade/Device Name: ReFix Internal Fracture Fixation Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: March 14, 2005 Received: March 15, 2005

Dear Mr. Huxel:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(t) premainted instally equivalent (for the indications
referenced above and have determined the device is substantial in interests a for use stated in the enclosure) the art acted predicate devices marketed in interstate for use stated in the enclosure) to regally mancetod proce Amendments, or to commerce prior to May 28, 1970, the chacanene with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosment Act (Act) that do not require to the general controls provisions of the Act. The Act. The Act. The You may, merelote, market the device, saloject or use ments for annual registration, listing of
general controls provisions of the Act include requirements michaeading and general controls provisions of the received required in the bronibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into or regulations affecting your device
it may be subject to such additional controls. Existing major regulation FDA it may be subject to such additional controls: "Intering and to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to Analysis can be lound in the Code of I edela. Regulation in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a subscribed with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a decemmanon that your acered by other Federal agencies. You must or any Federal statules and regulations administered of the registration and listing (21).
comply with all the Act's requirements, including, but not limited to set comply with all the Act S requirements, mendants, wartice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Fart on ); good manafanting production in electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the el forth in the quality systems (QB) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

{3}------------------------------------------------

Page 2- Mr. Shawn T. Huxel

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin makemig your article walness of your device to a legally
premarket notification. The FDA finding of substantial end the permits vour premarket notification. The I DA Inding of oublication 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
s and the may of the may on 1100 m Marceless and the regulation entitled If you desire specific advice for your de vice on our ac access note the regulation entitled,
contact the Office of Compliance at (240) 276-0120 . Also, please note the now o contact the Office of Comphalled at (240) 276 - 8 - 4 - 4 - 7 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 - 1 - 4 first from the Di "Misbranding by reference to premarket nonlication (1) of Act from the Division of Small .
other general information on your responsibilities under (800) 638-204) other general information on your responsion.comer Assistance at its toll-fire number (800) 638-2041 or Manufacturers, International and Consumer Assistantes artis courted to the result of the support/index.html.

Sincerely yours,

Stupt durelu

4 Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510 (K) NUMBER IF KNOWN: K043339
MANUFACTURER: Xtremi-T, LLC

DEVICE NAME: ReFIX Internal Fracture Fixation Pins

Indications:

ReFIX Biodegradable Pins are intended for use in the fixation and/or alignment of
ten the first and the collection beauts and arthrodeses; and ReFTX Biodegradable Plils are intention for assestomies and arthrodoses; and fragments of fractured mou-foad ocuring ochos, est. Secochondral fragments and
fixation and/or alignment of apical fragments, osteochondral fragments and
fixation and/or alig cancellous/non-load bearing fragments.

earses and

fixation of phalangeal fusion and fracture .
repair of metacarpal fusion and fracture �
fixation of hand and wrist fractures .
fixation of metatarsal osteotomies .
correction of hallux valgus .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use yes or Over-the-Counter Use No
(Per 21 CFR 801.109) (Optional Format 1-2-1996)

(Division Sign-Off)
Division of General, Restorative,

and Neurological Devices

510(k) Number K043339

Xtremi-T, LLC

Page 13 of 112

Confidential

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.