(92 days)
The Arthrex BioSync Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies, in the ankle and foot, such as:
Cotton and Evans Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy)
- Metatarsal/Cuneiform arthrodesis
Midfoot Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
This device is intended for use with ancillary fixation. The Arthrex BioSync Bone Wedge is not intended for use in the spine.
The Arthrex BioSync Bone Wedge is a family of pre-sized implantable titanium porous metal wedges intended to be used for angular correction of small bones in the ankle and foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.
This document is a 510(k) premarket notification for the Arthrex BioSync® Bone Wedge. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of submission.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific performance metrics. Instead, it states that "The submitted mechanical testing data, inclusive of static compression, dynamic compression and expulsion testing, demonstrates that the wedge is substantially equivalent to that of the predicate devices." This implies that the 'acceptance criteria' were likely equivalence to the mechanical properties of the predicate devices in these specific tests. No numerical performance results are provided for the Arthrex BioSync Bone Wedge itself.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a clinical study assessing a diagnostic or predictive device. The "test set" here refers to the Arthrex BioSync Bone Wedge, which underwent mechanical testing. The document does not specify the sample size of wedges used for these mechanical tests, nor does it discuss data provenance in terms of country of origin or retrospective/prospective nature, as these are typically clinical study considerations.
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)
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement equipment, not by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for human interpretation or clinical outcomes, not for mechanical device testing.
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 device is a bone wedge for surgical fixation, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As above, this is a surgical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical testing performed, the "ground truth" would be established by the physical and mechanical properties measured against established engineering standards and comparative data from the predicate devices. It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML device.
In summary, this 510(k) submission focuses on demonstrating the substantial equivalence of a medical device (Arthrex BioSync® Bone Wedge) to existing legally marketed predicate devices through mechanical testing. It does not involve acceptance criteria in the context of clinical performance, diagnostic accuracy, or AI model validation. The "study" mentioned is mechanical testing (static compression, dynamic compression, and expulsion testing) to show the new device performs similarly to the predicate devices in terms of its physical properties and mechanical resistance.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2015
Arthrex, Incorporated Ms. Laura Medlin Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K151256 Trade/Device Name: Arthrex BioSync® Bone Wedge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: PLF, HRS, HWC Dated: May 14, 2015 Received: May 22, 2015
Dear Ms. Medlin:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Ms. Laura Medlin
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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" (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.
Sincerelv vours.
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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TRADITIONAL 510(K): ARTHREX BIOSYNC BONE WEDGE
2.4 INDICATIONS FOR USE
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement below. |
Indications for Use
| 510(k) Number ( if known ) | K151256 |
|---|---|
| Device Name | Arthrex BioSync® Bone Wedge |
| Indications for Use ( Describe ) | The Arthrex BioSync Bone Wedge is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies, in the ankle and foot, such as: |
Cotton and Evans Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Opening wedge of Medial Cuneiform or Cotton osteotomies
- Lateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy)
- Metatarsal/Cuneifrom arthrodesis
Midfoot Wedges:
- Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
- Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)
This device is intended for use with ancillary fixation. The Arthrex BioSync Bone Wedge is not intended for use in the
spine.
| 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) |
|---|---|
| ---------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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2.5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | August 5, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Laura MedlinRegulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 72005Fax: 239/598.5508Email: Laura.Medlin@Arthrex.com |
| Trade Name | Arthrex BioSync Bone Wedge |
| Common Name | Plate, fixation, boneScrew, fixation, bone |
| Product Code,Classification Name | PLF – Bone WedgeHRS - Plate, Fixation, BoneHWC - Screw, Fixation, Bone |
| CFR | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Predicate Device | K140531: Wright Medical Technology, Inc. BIOFOAM® Bone WedgeK141635: Arthrex iBalance® TKA System |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex BioSync Bone Wedge. |
| Device Description | The Arthrex BioSync Bone Wedge is a family of pre-sized implantable titaniumporous metal wedges intended to be used for angular correction of small bones inthe ankle and foot. It is offered with varying widths and thicknesses toaccommodate a variety of small bone applications. |
| Intended Use | The Arthrex BioSync Bone Wedge is intended to be used for internal bone fixationfor bone fractures, fusions, or osteotomies in the ankle and foot, such as:Cotton and Evans Wedges:Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux ValgusOpening wedge of Medial Cuneiform or Cotton osteotomiesLateral Column Lengthening (Evans Lengthening Osteotomy of Calcaneal Z Osteotomy)Metatarsal/Cuneiform arthrodesisMidfoot Wedges:Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux ValgusNonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT or Lapidus)This device is intended for use with ancillary fixation. The Arthrex BioSync BoneWedge is not intended for use in the spine. |
| SubstantialEquivalence Summary | The Arthrex BioSync Bone Wedge is substantially equivalent to the predicatedevices, in which the basic design features and intended uses are the same. Anydifferences between the Arthrex BioSync Bone Wedge and the predicates areconsidered minor and do not raise questions concerning safety and effectiveness.The submitted mechanical testing data, inclusive of static compression, dynamiccompression and expulsion testing, demonstrates that the wedge is substantially |
| equivalent to that of the predicate devices. Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex, Inc. has determined that the Arthrex BioSync Bone Wedge is substantially equivalent to currently marketed predicate devices. |
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§ 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.