Nanova Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair

Nanova Screw-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair

Device Description

The NanovaTM Suture Anchor is comprised of two types: Screw-In and Push-In. Nanova™ Screw-In Suture Anchor is a cannulated, threaded, tapered anchor with integral eyelet for suturing soft tissue to bone. Nanova™ Push-In Suture Anchor is a cannulated anchor with integral evelet for suture soft tissue to bone. In addition the Push-In anchor can use a knotless technique by capturing suture. Suture anchors are preloaded with suture on a handled inserter with a hex driver. The device is made from a copolymer of absorbable 70-30 Poly-L/D-lactide (PLDLA) reinforced with hydroxyapatite. Nanoval Screw-In Suture Anchors are single use, prescription, long term implant, no drug.

AI/ML Overview

The provided document is a 510(k) premarket notification for two medical devices: the Nanova Screw-in Suture Anchor and the Nanova Push-in Suture Anchor. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or not provided in this type of submission. The information below reflects what can be extracted from the document within the context of a 510(k) submission.

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

For a 510(k) submission, the "acceptance criteria" are generally based on demonstrating "similar performance" to the predicate devices through non-clinical testing. The document states that the mechanical and performance testing resulted in "similar mechanical and performance to the predicate." No specific numerical acceptance criteria or detailed device performance metrics (e.g., in a table with target values) are provided beyond this general statement.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Pass ISO 10993 standards	All testing passed (based on risk assessment)
Mechanical & Performance	Similar to predicated devices	All testing passed, similar strength to predicates
NANOVA™ SCREW-IN SUTURE ANCHOR
Axial Pullout Strength	(Implied: Similar to predicate)	Tested, results were similar to predicate
Axial Fatigue Strength	(Implied: Similar to predicate)	Tested, results were similar to predicate
Max Torque	(Implied: Similar to predicate)	Tested, results were similar to predicate
Insertion Torque	(Implied: Similar to predicate)	Tested, results were similar to predicate
Immersion Pullout Strength	(Implied: Similar to predicate)	Tested, results were similar to predicate
NANOVA™ PUSH-IN SUTURE ANCHOR
Axial Pullout Strength	(Implied: Similar to predicate)	Tested, results were similar to predicate
Axial Fatigue Strength	(Implied: Similar to predicate)	Tested, results were similar to predicate
Immersion Pullout Strength	(Implied: Similar to predicate)	Tested, results were similar to predicate

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This information is not provided in the document. The document mentions "non-clinical performance testing" which includes mechanical and performance testing, but the specific number of units tested is not disclosed.
Data Provenance: The document does not specify the country of origin of the data or whether the testing was retrospective or prospective. Given it's non-clinical benchtop testing, these distinctions are less relevant than for clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable for this 510(k) submission. Ground truth establishment by experts (e.g., radiologists) is typically associated with clinical studies, especially those involving diagnostic devices or image interpretation. This submission focuses on the mechanical and biocompatibility properties of a physical implant (suture anchor), where "ground truth" would be determined by objective measurements and standardized testing protocols, not expert consensus on medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for this 510(k) submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for subjective assessments or when multiple readers provide conflicting interpretations (e.g., in radiology studies). The non-clinical testing described involves objective mechanical measurements where adjudication by multiple experts is not relevant.

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 information is not applicable for this 510(k) submission. MRMC studies, especially those focusing on AI assistance, are relevant for diagnostic devices or software that assist human readers in interpreting medical data. The Nanova Suture Anchor is a physical surgical implant, not a diagnostic or AI-enabled device, so an MRMC study would not be performed for this product.

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

This information is not applicable for this 510(k) submission. "Standalone performance" refers to the performance of an algorithm or software operating independently without human intervention, which is relevant for AI-powered diagnostic tools. As mentioned, the Nanova Suture Anchor is a physical surgical implant.

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

For the non-clinical performance testing, the "ground truth" would be derived from objective measurements obtained through standardized laboratory testing methods and equipment (e.g., force gauges for pullout strength, torque wrenches for insertion torque, etc.). There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these tests, as they are not clinical studies. The biocompatibility testing followed ISO 10993 standards, where "ground truth" is defined by the results meeting specific criteria or thresholds outlined in those standards.

8. The sample size for the training set

This information is not applicable for this 510(k) submission. "Training set" refers to data used to train machine learning algorithms. The Nanova Suture Anchor is a physical medical device, not an AI or software device that requires a training set.

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

This information is not applicable for this 510(k) submission, as there is no training set for a physical hardware device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 5, 2017

Nanova Biomaterials, Inc. Mr. Andrew Ritts Director of Regulatory Affairs 3806 Mojave Court Columbia, Missouri 65202

Re: K163672

Trade/Device Name: Nanova Screw-in Suture Anchor, Nanova Push-in Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: March 17, 2017 Received: March 27, 2017

Dear Mr. Ritts:

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. 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K163672

Device Name Nanova Push-In Suture Anchor

Indications for Use (Describe)

Nanova Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures

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

Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair

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

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
☑	☐

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Indications for Use

510(k) Number (if known) K163672

Device Name Nanova Screw-In Suture Anchor

Indications for Use (Describe)

Nanova Screw-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures

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

Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "NANOVA" in blue, with a slightly stylized font. The letters are bold and have a slight gradient effect, with the top of the letters being a lighter shade of blue than the bottom. The background is white.

510(k) Summary

Submitted By: 1)
Nanova Biomaterials, Inc 3806 Mojave Ct Columbia, MO 65202 USA 573-875-6682

Contact Person:	Andrew Ritts	Phone: (573) 823-3114
Secondary Contact:	Richard Lebens	Phone: (573) 875-6682

Establishment Registration No.: 2)
1. Date Prepared:
1. Device Trade Name:
1. Device Common Name:
Device Classification Name/ 6)

Product code/ Regulation number:

Classification Panel:

1. Device Class:

Predicated Devices:

Nanova™ Screw-In Suture Anchor is believed to be substantially equivalent to BioComposite Corkscrew (K082810).

Class II

Tissue/

3011430871

Suture Anchor

MAI/888.3030

Orthopedic

December 19, 2016

Nanova™ Screw-In Suture Anchor

Fastener, Fixation, Biodegradable, Soft

Nanova™ Push-In Suture Anchor is believed to be substantially equivalent to BioComposite PushLock (K082810) and Osteoraptor (K151105).

Indication for Use:

Nanova"M Screw-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
- Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair

{5}------------------------------------------------

NanovaTM Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/ wrist, and elbow in the following procedures

Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment; Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair

11) Device Description:

12) Substantial Equivalence:

The document, "Guidance on the CDRH Premarket Notification Review Program, 6/30/86 (K86-3)" was used to determine substantial equivalence:

a) The applicant device has the same intended use as the 510(k) cleared predicate listed above.

b) The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device. This device and its predicates use similar performance characteristics, manufacturing materials, and design. Nanova-10 Suture Anchor is packaged in a similar manner to its predicate and many 510k cleared products already on the market. Benchtop testing shows similar strengths between Nanova™ Suture Anchor and the

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the word "NANOVA" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is white, which makes the blue letters stand out.

predicates. Table 1 and 2 compares NanovaTM Suture Anchors to their predicates.

Table 1 Technological comparison of Nanova™ Screw-In Suture Anchor and
BioComposite Corkscrew (K082810).

Name	Nanova™ Screw-In Suture Anchor	BioComposite Corkscrew (K082810).
Intended use (same)	Fixation of suture (soft tissue) to bone	Fixation of suture (soft tissue) to bone
Sterility (same)	EtO at 10-6 SAL	EtO at 10-6 SAL
Configuration/ Dimensions (D=diameter, L=length, S= # of sutures)	4.5 mm D, 15 mm L, 2 S5.5 mm D, 15 mm L, 3 S6.5 mm D, 15 mm L, 3 S	4.5 mm D, 15 mm L, 2 S5.5 mm D, 15 mm L, 2 or 3 S6.5 mm D, 15 mm L, 2 or 3 S
Packaging (same)	Anchor loaded with suture on driver sealed in Tyvek pouch, which is then sealed in a foil pouch	Anchor loaded with suture on driver sealed in Tyvek pouch, which is then sealed in a foil pouch

		Table 2. Technical Comparison of Nanova "M Push-In Suture Anchor, Osteoraptor
	(K151105), and Bio-Composite PushLock (K082810).

Name	Nanova™ Push-InSuture Anchor	Osteoraptor (K151105).	Bio-CompositePushLock™ (K082810)
Intended Use	Fixation of suture (softtissue) to bone	Fixation of suture (softtissue) to bone	Fixation of suture (softtissue) to bone
Sterility(same)	EtO at 10-6 SAL	EtO at 10-6 SAL	EtO at 10-6 SAL
Configuration/Dimensions(D=diameter,L=length, S=# of sutures)	2.5 mm D, 12.6 mm L, 1S3.5 mm D, 12.6 mm L, 1S4.5 mm D, 12.6 mm L, 1S	2.3 mm* D, 15 mm L, 1S2.9 mm* D, 15 mm L, 1S	2.4 mm D, 11.3 mm L, 1S2.9 mm D, 15.5 mm L, 1S3.5 mm D, 19.5 mm L, 1S4.5 mm D, 28 mm L, 1S
Packaging(same)	Anchor loaded with sutureon driver sealed in Tyvekpouch, which is thensealed in a foil pouch	Anchor loaded with sutureon driver sealed in foilpouch	Anchor loaded with sutureon driver sealed in plastictray with Tyvek pouch,which is then sealed in afoil pouch

Osteoraptor size based off hole size, not anchor size

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "NANOVA" in blue, block letters. The letters are bold and sans-serif. The background is white.

In addition Nanova™ Suture Anchor and predicates are made from similar materials, polylactic acid and calcium phosphate composites. Performance strength of NanovaTM Suture Anchor is similar to their predicates.

Nanova™ Suture Anchor has the same Intended Use as the predicate devices to which it was compared, and there are no differences in technological characteristics which raise new questions of safety and / or effectiveness. Therefore, Nanova"M Suture Anchor is substantially equivalent.

1. Non-Clinical Performance Testing:
  Non-clinical testing was completed to assess its performance. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility risk assessment conducted and a benchtop assessment. ISO 10993 was utilized for testing biocompatibility (all testing passed). Mechanical and performance testing was compared with the predicate, which resulted in similar mechanical and performance to the predicate (all testing passed). Nanova™ Screw-In Suture Anchor was tested by: axial pullout strength, axial fatigue strength, max torque, insertion torque, and immersion pullout strength. Nanova™ Push-In Suture Anchor was tested by: axial pullout strength, axial fatigue strength, and immersion pullout strength.
1. Clinical Performance Testing: Clinical performance data was not included.

Conclusion:

Nanova Biomaterials Inc. believes that Nanova™ Suture Anchor is substantially equivalent to currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or safety risks.

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.