The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure:
shoulder, foot/ankle, knee, hand/wrist and elbow.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Device Description

The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a medical device called "Fix2Lock" (a bone anchor). This type of document primarily focuses on establishing substantial equivalence to a predicate device based on non-clinical performance data (bench tests). It does not contain information about clinical studies involving human patients, human readers (e.g., radiologists interpreting images), or AI algorithms for diagnostic purposes.

Therefore, I cannot provide details on:

Acceptance criteria related to AI performance (e.g., sensitivity, specificity).
Sample sizes for test sets or data provenance for AI.
Number of experts or their qualifications for establishing ground truth for AI.
Adjudication methods for AI test sets.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone AI performance.
Training set details for AI.

The document discusses bench testing to demonstrate the device's mechanical and material properties, and sterility, compared to existing standards and a predicate device.

Here's the information that can be extracted relevant to the performance and acceptance criteria for this specific type of medical device, which is a bone anchor, not an AI diagnostic tool:

Acceptance Criteria and Study for the Fix2Lock Device

The acceptance criteria and supporting studies for the Fix2Lock device are based on non-clinical (bench) testing, primarily to demonstrate that the device meets established material and mechanical performance standards and is substantially equivalent to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Category / Standard	Acceptance Criteria (Implied by Compliance)	Reported Device Performance (Implied by "met all design specifications" and "complies")
Material Standards	Compliance with:	Confirmed compliance based on bench tests
ASTM F2026: 2017	Polyetheretherketone (PEEK) polymers for surgical applications met standard requirements.	Met.
ASTM F2848: 2021	Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants met standard requirements.	Met.
ASTM F2502: 2017	Absorbable Plates and Screws for Internal Fixation Implants (materials aspects) met standard requirements.	Met.
Mechanical Performance Standards	Compliance with:	Confirmed compliance based on bench tests
ASTM F543: 2013	Metallic Medical Bone Screws (mechanical aspects) met standard requirements.	Met.
ASTM F2502: 2017	Absorbable Plates and Screws for Internal Fixation Implants (mechanical aspects) met standard requirements.	Met.
Sterilization, Shelf-life & Packaging Standards	Compliance with:	Confirmed compliance based on bench tests
ISO 11135:2014	Ethylene oxide sterilization process requirements.	Met.
ISO 11138-1:2017, ISO 11138-2:2017	Biological indicators for sterilization processes.	Met.
ISO 11140-1:2014	Chemical indicators for sterilization.	Met.
ISO 11737-1:2018 (incl. AMD1:2021)	Microbiological methods for determination of microorganism population on product.	Met.
ISO 11737-2:2019	Sterility tests.	Met.
ISO 11607-1:2019	Requirements for materials, sterile barrier systems, and packaging systems.	Met.
ISO 11607-2:2019	Validation requirements for forming, sealing, and assembly processes.	Met.
ASTM F1980:2016	Accelerated Aging of Sterile Barrier Systems.	Met.
ASTM F88/F88M:2021	Seal strength of flexible barrier materials.	Met.
ASTM F1929:2015	Detecting Seal Leaks in Porous Medical Packaging.	Met.
Bacterial Endotoxin Testing	Compliance with:	Confirmed compliance based on bench tests
USP <85>, USP <161>	Bacterial Endotoxin Test and Pyrogen Tests.	Met.
ISO 11737-3:2023	Bacterial endotoxin testing methods.	Met.
Product Size Comparison (vs. Predicate)	Anchor diameter: Ø 3.75 to 6.5 mm; Anchor length: 12.0 to 14.0 mm	Matches or is within the range of the predicate device (Ø 2.6 to 6.5 mm diameter, 10.0 to 20.8 mm length). Safety evaluated by performance bench tests.
Shelf-life	3 Years	3 Years (Matches predicate)

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes (number of units) used for each bench test. However, it indicates that "Bench tests were conducted to verify that the subject device met all design specifications."
Data Provenance: Not applicable in the human patient context. The data is from laboratory bench testing of the physical medical device. The sponsor is OSTEONIC Co., Ltd. from Korea, South. The testing would have been conducted by or for the manufacturer.

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

Not applicable. Ground truth for this type of device is established through compliance with recognized consensus standards (e.g., ASTM, ISO) and comparison of physical/mechanical properties to a predicate device via laboratory testing, not through expert human interpretation of data like in an AI study.

4. Adjudication method for the test set:

Not applicable. Bench tests have objective, measurable endpoints based on engineering and material science principles, not subjective interpretation requiring adjudication.

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:

No. This is a physical medical device (bone anchor), not an AI diagnostic software.

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

No. This applies to AI algorithms, not physical implanted devices.

7. The type of ground truth used:

The "ground truth" for this device is compliance with established engineering, material, and sterilization standards (ASTM and ISO standards) and demonstration of equivalent performance characteristics (material, mechanical, sterilization properties) compared to a legally marketed predicate device through objective bench testing.

8. The sample size for the training set:

Not applicable. There is no AI training set for this physical device.

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

Not applicable. There is no AI training set.

Summary

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December 3, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

OSTEONIC Co., Ltd. % Lee Sanglok Manager WISE COMPANY Inc. #1107, #1108, 204 Gasandigital 1-ro, Geumcheon-gu Seoul. 08502 Korea, South

Re: K243467

Trade/Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: November 8, 2024 Received: November 8, 2024

Dear Lee Sanglok:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K243467

Device Name

Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

Indications for Use (Describe)

The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure:

shoulder, foot/ankle, knee, hand/wrist and elbow.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ne-Counter Use (21 CFR 801 Subpart C)

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Date of Submission: 2024.11.08

01. Applicant

OSTEONIC Co., Ltd.

405Ho, 505-2Ho, 505-3Ho, 508Ho, 603Ho, 902Ho, 1004Ho, 1005Ho, 1202Ho, 1206Ho, 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea, 102Ho, 103Ho, 24 Digital-ro 27-gil, Guro-gu, Seoul, Korea, 1012Ho, 1013Ho, 272, Digital-Ro, Guro-gu, Seoul, Korea TEL: +82-2-6902-8400 FAX: +82-2-6902-8401 Email: dakham@osteonic.com

02. Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. 1107Ho, 1108Ho, 204 Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org

03. Subject Device Identification

Trade Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Common Name: Bioabsorbable bone anchor Classification Name: fastener, fixation, biodegradable, soft tissue Classification Product Code: MAI Subsequent Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3030 Device Class: II

04. Predicate device

510(k) Number: K202806, K231326 Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Manufacturer: Osteonic Co., Ltd.

05. Reference device

N/A

06. Device Description

The Fix2Lock (Bioabsorbable bone anchor) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

07. Indication for use

The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

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Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral

ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

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08. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:

▪ Material

ASTM F2026: 2017 Standard specification for polyetheretherketone(PEEK) polymers for surgications - ASTM F2848: 2021 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants
ASTM F2502: 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

▪ Mechanical performance

ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
ASTM F2502: 2017 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

▪ Sterilization, shelf-life and packaging for sterile product

ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development validation and routine control of a sterilization and routine control of a sterilization process for medical devices
ISO 11138-1:2017, Sterilization of health care products Biological indicators Part 1: General requirements
ISO 11138-2:2017, Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11140-1:2014, Sterilization of health care products -- Chemical indicators -- Part 1: General requirements
ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product [Including Amendment 1 (2021)]
ISO 11737-2:2019 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11607-1:2019 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
ISO 11607-2:2019 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F88/F88M:2021 Standard test method for seal strength of flexible barrier materials.
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Bacterial Endotoxin
USP <85> Bacterial Endotoxin Test
USP <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
ISO 11737-3:2023, Sterilization of health care products Microbiological methods Part 3: Bacterial endotoxin testing

09. Comparison of Technological Similarities and Differences

Table 1: Substantial Equivalence Comparison

Product Name	SUBJECT Device	Predicate DeviceFix2Lock(Biocomposite medial, lateral,Biocombi Self Punching)(K231326,K202806)	EquivalenceDiscussion
Product code	MAI	MAI	Same
Regulatory class	Class II	Class II	Same
Regulation Number	21 CFR 888.3030	21 CFR 888.3030	Same
Intended use	The Fix2Lock is intended use for fixationof soft tissue to bone, using suture, in thefollowing procedure;shoulder, foot/ankle, knee, hand/wrist andelbow.Shoulder: Rotator Cuff Repair, BankartRepair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation.	The Fix2Lock is intended use for fixationof soft tissue to bone, using suture, in thefollowing procedure;shoulder, foot/ankle, knee, hand/wrist andelbow.Shoulder: Rotator Cuff Repair, BankartRepair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation.	Same

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	Repair, Deltoid Repair, Capsular Shift orCapsulolabral ReconstructionFoot/Ankle: Lateral Stabilization, MedialStabilization, Achilles Tendon Repair,Metatarsal Ligament Repair, HalluxValgus reconstruction, digital tendontransfers, Mid-foot reconstructionKnee: Medial Collateral Ligament Repair,Lateral Collateral Ligament Repair, PatellarTendon Repair, Posterior ObliqueLigament Repair, Iliotibial Band TenodesisHand/Wrist: Scapholunate LigamentReconstruction, Carpal LigamentReconstruction, Repair/Reconstruction ofcollateralligaments, Repair of Flexor and ExtensorTendons at the PIP, DIP, and MCP jointsfor all digits, digital tendon transfersElbow: Biceps Tendon Reattachment,Ulnar or Radial Collateral LigamentReconstruction	Repair, Deltoid Repair, Capsular Shift orCapsulolabral ReconstructionFoot/Ankle: Lateral Stabilization, MedialStabilization, Achilles Tendon Repair,Metatarsal Ligament Repair, HalluxValgus reconstruction, digital tendontransfers, Mid-foot reconstructionKnee: Medial Collateral Ligament Repair,Lateral Collateral Ligament Repair, PatellarTendon Repair, Posterior ObliqueLigament Repair, Iliotibial Band TenodesisHand/Wrist: Scapholunate LigamentReconstruction, Carpal LigamentReconstruction, Repair/Reconstruction ofcollateralligaments, Repair of Flexor and ExtensorTendons at the PIP, DIP, and MCP jointsfor all digits, digital tendon transfersElbow: Biceps Tendon Reattachment, Ulnaror Radial Collateral LigamentReconstruction
OperatingPrinciples	Bone fixation screw that ties soft tissuessuch as ligament, tendon, and the articularcapsules to bone.	Bone fixation screw that ties soft tissuessuch as ligament, tendon, and the articularcapsules to bone.	Same

Material	Anchor:-Biocomposite medial, lateral: PLGA+β-TCP-Biocombi self punching: PLGA+β-TCP,PEEKSuture: UHMWPE	Anchor:-Biocomposite medial, lateral: PLGA+β-TCP-Biocombi self punching: PLGA+β-TCP,PEEKSuture: UHMWPE	Same
Structure	This product consists of an absorbableand/or non-absorbable anchor, a non-absorbable suture, needle and driver shaftand handle.	This product consists of an absorbableand/or non-absorbable anchor, a non-absorbable suture and driver shaft andhandle.	Same
ProductSize	Anchor diameter: Ø 3.75 to 6.5 mmAnchor length: 12.0 to 14.0mm	Anchor diameter: Ø 2.6 to 6.5 mmAnchor length: 10.0 to 20.8mm	Similar
Sterilization	Sterile (EtO sterilization)	Sterile (EtO sterilization)	Same
Single Use/Reuse	Single use	Single use	Same
Packaging	1 EA / BOX	1 EA / BOX	Same
Shelf-life	3Years	3Years	Same

The Product Size of subject device is similar with the predicate device. It is not exactly same but the is within the range of unmodified device and the safety was evaluated as the performance bench test.

10. Substantially Equivalent Conclusion

Based on above, the subject device, Fix2Lock (Biocomposite medial, lateral, Biocombi Self punching), is determined to be Substantially Equivalent (SE) to the predicate device(Unmodified device), Fix2Lock(Biocomposite medial, lateral, Biocombi Sef pundhing), (K202806, K231326) in respect of safety and effectiveness.

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.