The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast and brace). The Stryker SonicPin is designed only to be inserted with the SonicFusion equipment.

The Stryker SonicAnchor System is intended to be used for suture or tissue fixation in open procedures in the foot, ankle, knee, hand, wrist, elbow and shoulder. The Stryker SonicAnchor is designed only to be inserted with the SonicFusion equipment.
Indications Include:
Foot/Ankle
• Achilles Tendon Repair
• Lateral Stabilization
• Medial Stabilization
• Hallux Valgus Reconstruction
• Midfoot Reconstruction
• Metatarsal Ligament Repair
• Digital Tendon Transfer
Shoulder
• Acromio-Clavicular Separation Repair
• Proximal Deltoid Repair
Elbow
• Ulnar or Radial Collateral Ligament Reconstruction
Knee
• Patellar Tendon Repair
Hand/Wrist
• Scapholunate Ligament Reconstruction
• Carpal Ligament Reconstruction
• Repair/Reconstruction of Collateral Ligaments

Device Description

Stryker SonicPin System: The Stryker SonicPin System consists of a sterile bioresorbable pin implant, the SonicFusion equipment and associated accessories intended for the internal fixation of bone fractures and fragments. The pin is made of PLDLLA (Poly(L-lactide-co-D.L-lactide) which has been evaluated for magnetic resonance safety and is implanted using SonicFusion technology which is a process that employs ultrasonic energy to liquefy a polymer and facilitate a fixed interface between the implant and host bone. The associated accessories include: SonicFusion equipment, Drill, Handpiece Tip, TipTool, Direct Depth Gauge.

Stryker SonicAnchor System: The Stryker SonicAnchor System consists of a bioresorbable anchor with suture implant, the SonicFusion equipment and associated accessories intended for the fixation of suture or soft tissue to cancellous bone. The implant is comprised of the anchor, made of PLDLLA (Poly(L-lactide-co-D,L-lactide) which has been evaluated for magnetic resonance safety and a Teleflex Force Fiber suture, made of braided ultrahigh molecular weight polyethylene (UHMWPE) and polypropylene (PP) strands. The associated accessories include: SonicFusion equipment, Drill, Handpiece Tip, TipTool.

AI/ML Overview

This document describes the Stryker SonicPin System and the Stryker SonicAnchor System, both of which utilize the SonicFusion equipment. The information provided outlines the regulatory clearance for these devices based on substantial equivalence to predicate devices, supported primarily by non-clinical testing.

Here's an analysis of the acceptance criteria and the supporting study information based on the provided text:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are implicitly defined by the performance of the predicate devices and general safety/effectiveness standards for the device type. The "reported device performance" refers to the results of the non-clinical tests conducted to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Stryker SonicPin System:
Implantation process equivalent after modifications to SonicFusion equipment.	Successful completion of Tensile Strength Testing to evaluate implantation process with modifications.
Magnetic Resonance (MR) safety established.	Magnetic resonance evaluated as per FDA Guidance (2008).
Biocompatibility established.	Biocompatibility testing (Irritation, Sensitization, Cytotoxicity, Biological Compatibility Risk Assessment) conducted.
Electrical safety and Electromagnetic Compatibility (EMC) of SonicFusion equipment validated.	SonicFusion equipment complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).
Software verification and validation for SonicFusion equipment.	Software V&V completed as per FDA guidance for "moderate" level of concern.
Stryker SonicAnchor System:
Mechanical performance comparable to predicate.	Successful completion of Dynamic Fatigue Strength Testing comparing subject to predicate device.
Magnetic Resonance (MR) safety established.	Magnetic resonance evaluated as per FDA Guidance (2008).
Ultrasound heat safety established.	Ultrasound heat safety evaluated as per FDA Guidance (2008).
Biocompatibility established.	Biocompatibility testing (Irritation, Sensitization, Cytotoxicity, Genotoxicity, Biodegradation, Biological Compatibility Risk Assessment) conducted.
Electrical safety and Electromagnetic Compatibility (EMC) of SonicFusion equipment validated.	SonicFusion equipment complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).
Software verification and validation for SonicFusion equipment.	Software V&V completed as per FDA guidance for "moderate" level of concern.

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

The document does not specify sample sizes for any of the mechanical, biocompatibility, electrical safety, EMC, or software verification tests.
The data provenance is not explicitly stated as country of origin, retrospective, or prospective. However, based on the nature of the tests (mechanical, biocompatibility, electrical, software), these are typically performed in a controlled laboratory or testing facility environment, usually prospective for a regulatory submission. The submitter is Stryker Trauma GmbH, Germany.

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 as the studies are primarily non-clinical engineering and laboratory tests (mechanical, biocompatibility, electrical, software). There is no mention of expert-established ground truth in a clinical context for these tests.

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

This information is not applicable. Adjudication methods are typically used in clinical trial settings, especially for establishing ground truth from multiple readers/observers. The described studies are non-clinical engineering and laboratory tests.

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, an MRMC comparative effectiveness study was not done. This submission is for medical devices (pins and anchors) and associated equipment, not an AI or imaging diagnostic device.

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

This concept is not applicable to these medical devices. These are physical implants and associated surgical tools, not an algorithm.

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

For the mechanical testing, the "ground truth" is defined by established engineering principles and standards for evaluating material properties and device performance (e.g., tensile strength, fatigue strength).
For biocompatibility testing, the "ground truth" is established by recognized international standards (ISO 10993 series) and FDA guidance for biological evaluation.
For electrical safety and EMC, the "ground truth" is compliance with international standards (IEC 60601-1, IEC 60601-1-2).
For software verification and validation, the "ground truth" is the successful execution of planned tests according to predefined specifications as outlined in FDA guidance.
No expert consensus, pathology, or outcomes data (clinical ground truth) were used, as clinical testing was not required.

8. The sample size for the training set

This information is not applicable. There is no "training set" as these are not machine learning or AI models.

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

This information is not applicable as there is no "training set."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling 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

January 27, 2015

Stryker Trauma GmbH Ms. Estela Celi Senior Regulatory Affairs Specialist 325 Corporate Mahwah, New Jersey 07430

Re: K143063 Trade/Device Name: Stryker SonicPin System SonicAnchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, MAI, GAT Dated: October 22, 2014 Received: October 29, 2014

Dear Ms. Celi:

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

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Page 2 - Ms. Estela Celi

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143063

Device Name Stryker SonicPin System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143063

Device Name Stryker Sonic Anchor System

Indications for Use (Describe)

Foot/Ankle
• Achilles Tendon Repair
• Lateral Stabilization
• Medial Stabilization
• Hallux Valgus Reconstruction
• Midfoot Reconstruction
• Metatarsal Ligament Repair
• Digital Tendon Transfer
Shoulder
• Acromio-Clavicular Separation Repair
• Proximal Deltoid Repair
Elbow
• Ulnar or Radial Collateral Ligament Reconstruction
Knee
• Patellar Tendon Repair
Hand/Wrist
• Scapholunate Ligament Reconstruction
• Carpal Ligament Reconstruction
• Repair/Reconstruction of Collateral Ligaments

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)
----------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary

Submitter:	Stryker Trauma GmbHProf. Kuetscher Str. 1-524232 SchönkirchenGermanyPhone: (201) 831-6461Fax: (201) 831-3461
Contact Person:	Estela CeliSenior Regulatory Affairs Specialist
DeviceName of Device:	Stryker SonicPin System/SonicAnchor System
Common Name:	Stryker SonicPin System- Smooth Fixation Pin
	Stryker SonicAnchor System-Smooth Fixation Pin/Fastener& Suture
Classification Name:	Stryker SonicPin SystemSmooth or threaded metallic bone fixation fastener21 CFR §888.3040
	Stryker SonicAnchor SystemSingle/multiple component metallic bone fixationappliances and accessories.21 CFR §888.3030Nonabsorbable poly(ethylene terephthalate) surgicalsuture21 CFR §878.5000
Regulatory Class:Product Code:	IIStryker SonicPin System: HTYStryker SonicAnchor System: MAI, GAT
Predicate Devices:	Stryker SonicPin SystemPrimary Predicate: Stryker SonicPin System-K091955
	Stryker SonicAnchor SystemPrimary Predicate-Arthrex 2.5 mm PushLock -K063479Reference Device- Stryker SonicPin System-K091955
Date Prepared:	October 22, 2014

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Description:

Stryker SonicPin System

This Traditional 510(k) submission is being supplied to the U.S. FDA to seek clearance for modifications made to the Stryker SonicPin System, with regard to the SonicFusion equipment and included in the previously cleared Stryker SonicPin System under K091995 and the addition of accessories. The Stryker SonicPin System consists of a sterile bioresorbable pin implant, the SonicFusion equipment and associated accessories intended for the internal fixation of bone fractures and fragments. The pin is made of PLDLLA (Poly(L-lactide-co-D.L-lactide) which has been evaluated for magnetic resonance safety and is implanted using SonicFusion technology which is a process that employs ultrasonic energy to liquefy a polymer and facilitate a fixed interface between the implant and host bone.

The associated accessories include:

SonicFusion equipment
. Drill
Handpiece Tip
TipTool ●
Direct Depth Gauge ●

Stryker SonicAnchor System

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Stryker SonicAnchor System. The Stryker SonicAnchor System consists of a bioresorbable anchor with suture implant, the SonicFusion equipment and associated accessories intended for the fixation of suture or soft tissue to cancellous bone. The implant is comprised of the anchor, made of PLDLLA (Poly(L-lactide-co-D,L-lactide) which has been evaluated for magnetic resonance safety and a Teleflex Force Fiber suture, made of braided ultrahigh molecular weight polyethylene (UHMWPE) and polypropylene (PP) strands.

The associated accessories include: ● SonicFusion equipment
- Drill ●
- Handpiece Tip
- TipTool ●

Intended Use:

Stryker SonicPin System

Both the subject and predicate have the same intended use for the internal fixation of bone fractures and fragments.

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Stryker SonicAnchor System

Both the subject and predicate have the same intended use for the fixation of suture or soft tissue to cancellous bone.

Indications for Use:

Stryker SonicPin System

Stryker SonicAnchor System

Foot/Ankle

. Achilles Tendon Repair
Lateral Stabilization ●
Medial Stabilization ●
Hallux Valgus Reconstruction ●
Midfoot Reconstruction ●
Metatarsal Ligament Repair ●
Digital Tendon Transfer

Shoulder

Acromio-Clavicular Separation Repair ●
Proximal Deltoid Repair

Elbow

Ulnar or Radial Collateral Ligament Reconstruction ●

Knee

. Patellar Tendon Repair

Hand/Wrist

Scapholunate Ligament Reconstruction
Carpal Ligament Reconstruction ●
Repair/Reconstruction of Collateral Ligaments ●

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Comparison of Technological Characteristics with the Predicate Device:

Stryker SonicPin System

SonicFusion is the technological principle for both the subject Stryker SonicPin System and the predicate Stryker SonicPin System. SonicFusion technology is based on the application of controlled ultrasonic energy which liquefies the polymer implant as it is placed in the bone. At a high level, the subject and predicate devices are based on the following same technological elements:

. Use of a polymer pin implant
SonicFusion technology used for implant application ●

The following differences exist between the subject and predicate devices:

Sonic Pin implant material has been evaluated for magnetic resonance safety ●
New SonicFusion ultrasonic generator, handpiece and footswitch
Use of interchangeable tips on the SonicFusion handpiece
Ultrasound delivered has a decreased amplitude
Added footswitch containing power switch to SonicFusion equipment ●

Stryker SonicAnchor System

The Stryker SonicAnchor System and the predicate device are both intended to be used for suture or tissue fixation to bone.

At a high level, the subject and predicate devices require the following same technological elements:

Surgical site preparation
. Use of a drill for surgical site preparation
Use of a suture ●

The following differences exist between the subject and predicate devices:

Use of different fixation methods

Performance Data:

Mechanical Testing

Stryker SonicPin System

Mechanical testing was performed to evaluate the implantation process with the modifications made to the SonicFusion equipment.

. Tensile Strength Testing
Additionally the magnetic resonance was evaluated as per FDA Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, 2008.

Stryker SonicAnchor System

Testing was completed to evaluate mechanical performance of the subject device compared against the predicate.

Dynamic Fatigue Strength Testing

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Additionally the magnetic resonance safety and ultrasound heat safety were evaluated as per FDA Guidance for Industry and FDA Staff - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, 2008.

Biocompatibility Testing

The biocompatibility evaluation for the Stryker SonicPin System and Stryker SonicAnchor System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Stryker SonicPin System

Rationales for Irritation and Sensitization testing
Cytotoxicity ●
. Biological Compatibility Risk Assessment

Stryker SonicAnchor System

Rationales for Irritation and Sensitization testing ●
Cytotoxicity
Genotoxicity ●
Biodegradation ●
. Biological Compatibility Risk Assessment

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the SonicFusion equipment used in both the Stryker SonicPin System and the Stryker SonicAnchor System, consisting of the ultrasonic generator, handpiece and footswitch. The SonicFusion equipment complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 Edition 3: 2007-03 standards for EMC.

Software Verification and Validation Testing

Software verification and validation testing was completed on the SonicFusion equipment, used in both the Stryker SonicPin System and the Stryker SonicAnchor System, was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Clinical Testing:

Stryker SonicPin System

Clinical testing was not required to support substantial equivalence of the proposed Stryker SonicPin System to the predicate SonicPin System.

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Stryker SonicAnchor System

Clinical testing was not required to support substantial equivalence of the Stryker SonicAnchor System in comparison to the predicate device.

Conclusion:

Stryker SonicPin System

Modifications made to the Stryker SonicPin System have been evaluated in comparison to the predicate device and non-clinical data have been used to support substantial equivalence. The hardware and software verification and validation for the SonicFusion equipment demonstrate that the subject Stryker SonicPin System should perform as intended in the specified use conditions.

Stryker SonicAnchor System

The non-clinical data for the Stryker SonicAnchor System including the SonicFusion equipment support the safety of the device and demonstrates that the Stryker SonicAnchor System performs comparably to the predicate device that is currently marketed for the same intended 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.