· 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 or 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 BIOFOAM® Bone Wedge is not intended for use in the spine.

Device Description

The BIOFOAM® Bone Wedge is a titanium metal foam wedge used for angular correction of small bones of the foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.

AI/ML Overview

This document is a 510(k) premarket notification for the BIOFOAM® Bone Wedge, a medical device. The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance from a study in the typical sense of algorithm or diagnostic device evaluation.

Therefore, the requested information cannot be fully provided as it pertains to a different type of regulatory submission (a medical device 510(k) which primarily relies on demonstrating substantial equivalence, especially based on non-clinical evidence in this case, rather than demonstrating performance against specific clinical acceptance criteria).

Here's an analysis of the provided text in relation to your questions:

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

This information is not present in the document. 510(k) submissions typically do not include 'acceptance criteria' in the same way an AI/diagnostic device validation study would. Instead, they demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "performance" reported is primarily in the context of non-clinical testing to show this equivalence.

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

This information is not applicable/not present in the context of the provided document. This 510(k) relies on non-clinical testing (morphological characterization, abrasion, friction, compression, fatigue, biocompatibility) rather than a clinical test set with patient data.

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/not present. Ground truth, as typically understood in diagnostic or AI device studies, is not established for this type of non-clinical testing.

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

This information is not applicable/not present.

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/not present. This is a physical bone wedge, not an AI or diagnostic tool that would involve human readers.

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

This information is not applicable/not present. This is a physical bone wedge.

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

This information is not applicable/not present. The "truth" in this context is established by engineering and material science standards for the non-clinical tests.

8. The sample size for the training set

This information is not applicable/not present. There is no "training set" as this is not an AI/machine learning device.

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

This information is not applicable/not present.

Summary of what is available in the document regarding "study" and "performance":

The document states:

Study Type: Non-clinical (bench testing) and biocompatibility testing.
Tests Conducted: Morphological characterization, abrasion, friction, compression, fatigue, chemical composition, and animal testing.
Purpose of Tests: To support the equivalence of the subject device (BIOFOAM® Bone Wedge) to its predicate devices and demonstrate that "no new worst-case devices are introduced in this system."
Conclusion from Tests: "The safety and effectiveness of the BIOFOAM® Bone Wedge is adequately supported by testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification."
Clinical Evidence: Explicitly stated as "N/A" (Not Applicable), indicating no clinical studies were performed or submitted.

This 510(k) submission successfully demonstrated substantial equivalence based on non-clinical evidence only, which is common for devices of this type.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, representing health and human services.

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

May 20, 2015

Wright Medical Technology, Incorporated Ms. Val Myles Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

Re: K142724

Trade/Device Name: BIOFOAM® 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: HRS, HWC Dated: April, 17, 2015 Received: April 20, 2015

Dear Ms. Myles:

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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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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,

Lori A. Wiggins -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known)

K142724

Device Name BIOFOAM® Bone Wedge

Indications for Use (Describe)

The BIOFOAM® Bone Wedge is intended to be used for internal 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 or 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 BIOFOAM® Bone Wedge is not intended for use in the spine.

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

X 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)

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Headquarters Wright Medical Technology, Inc.

Memphis TN 38117

01 867 997

510(K) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the WMT BIOFOAM® Bone Wedge.

(a)(1). Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
Date:	September 22, 2014
Contact Person:	Val MylesRegulatory Affairs SpecialistOffice - (901) 290-5162Fax - (901) 867-4190
(a)(2). Proprietary Name:	BIOFOAM® Bone Wedge
Common Name:	Bone Wedge
Classification Name and Reference:	21 CFR 888.3030 – Class II
Device Product Code, Device Panel:	HRS, HWC
(a)(3). Predicate Devices:	K140531, K093950, K073535: BIOFOAM®Bone WedgeK070592: Small Bone Wedge

(a)(4). Device Description

(a)(5). INTENDED USE

The BIOFOAM® 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 or Calcaneal Z Osteotomy)

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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 BIOFOAM Bone Wedge is not intended for use in the spine.

(a)(6). Technological Characteristics Comparison

While the subject BIOFOAM® Bone Wedge is manufactured using a modified manufacturing technique, it is technologically substantially equivalent to the predicate device. The subject and predicate devices are substantially equivalent in design, features and material.

(b)(1). Substantial Equivalence - Non-Clinical Evidence

Testing related to morphological characterization, abrasion, friction, compression and fatigue were provided to support the equivalence of the subject device and shows that no new worst-case devices are introduced in this system. Biocompatibility testing, including chemical composition and animal testing, was also completed to support the equivalence of the subject device. The safety and effectiveness of the BIOFOAM® Bone Wedge is adequately supported by testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket notification.

(b)(2). Substantial Equivalence - Clinical Evidence

N/A

(b)(3). Substantial Equivalence - Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate device.

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.