Biomet Reconstructive Wedges are intended to be used for internal bone fixation for bone structures, fusions or osteotomies in the ankle and foot, such as:

Open wedge osteotomies of Hallux Valgus .
Evans lengthening osteotomies .
Metatarsal/cuneiform arthrodesis .

Biomet Reconstructive Wedges are intended for use with ancillary fixation.

Biomet Reconstructive Wedges are not intended for use in the spine.

Device Description

Biomet Reconstructive Wedges are metallic blocks designed for insertion into voids for alignment of bones in the foot or ankle. There are two styles of wedges which are oval and rectangular in shape. Wedges are available in a variety of widths, lengths and thicknesses. Rectangular cut-out windows allow the surgeon to pack allograft within the device. The wedges are completely porous, to allow for tissue ingrowth. There is a "skin" of solid titanium on the outer edge of the component to facilitate the insertion instrument and allow for identifying part marking to be added to the devices.

AI/ML Overview

The Biomet Reconstructive Wedges are metallic blocks designed for insertion into voids for alignment of bones in the foot or ankle. The device comes in two styles (oval and rectangular) and various sizes. It features rectangular cut-out windows for allograft packing and is completely porous for tissue ingrowth, with a solid titanium "skin" on the outer edge.

Here's an analysis of the acceptance criteria and study data:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Functional performance within intended use.	"The results of testing indicated the material performed within the intended use..." Specific quantitative criteria are not listed in this document.
No new safety and efficacy issues raised.	"...did not raise any new safety and efficacy issues..."
Substantial equivalence to predicate devices.	"...and were found to be substantially equivalent to the predicate devices." (Specifically to Wright Medical Technology Inc.'s BIOFOAM® Bone Wedges cleared through K070592, K073535, and K093950).
Acceptable Chemical Composition	Non-Clinical Test Performed. Results not explicitly detailed but implied as acceptable for substantial equivalence.
Acceptable Static Shear Strength	Non-Clinical Test Performed. Results not explicitly detailed.
Acceptable Static Compression Testing	Non-Clinical Test Performed. Results not explicitly detailed.
Acceptable Dynamic Compression Testing	Non-Clinical Test Performed. Results not explicitly detailed.
Acceptable Expulsion Testing	Non-Clinical Test Performed. Results not explicitly detailed.
Acceptable Compressive Strength	Non-Clinical Test Performed. Results not explicitly detailed.
Acceptable Porosity/Pore Size	Non-Clinical Test Performed. Results not explicitly detailed.
Acceptable Taber Abrasion	Non-Clinical Test Performed. Results not explicitly detailed.
Acceptable Interconnectivity	Non-Clinical Test Performed. Results not explicitly detailed.
Acceptable Roughness	Non-Clinical Test Performed. Results not explicitly detailed.
Acceptable Tensile Adhesion	Non-Clinical Test Performed. Results not explicitly detailed.
MR Compatibility	Non-Clinical Test Performed. Results not explicitly detailed.
Acceptable Microstructure	Non-Clinical Test Performed. Results not explicitly detailed.
No adverse animal data (if applicable)	Animal Data was collected as a Non-Clinical Test, implying results were acceptable.
No need for clinical data for substantial equivalence	"No clinical data was necessary for a determination of substantial equivalence." and "No clinical data submitted." This indicates that non-clinical data was sufficient to meet the regulatory standard for this device type and its predicate.

Sample size used for the test set and the data provenance:
- The document primarily references non-clinical tests. These tests likely involved a sample size of material specimens or device prototypes as per relevant ASTM or ISO standards for testing medical implants. However, the exact sample sizes for each specific test are not mentioned in this summary.
- Data provenance: Not specified in the provided summary (e.g., country of origin). The studies are non-clinical, meaning they were likely laboratory or bench-top tests. The document states "No clinical data submitted," so there is no patient data provenance to describe.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Since this submission relies on non-clinical performance data and does not involve AI or human interpretation of medical images/data, there is no mention of experts establishing a "ground truth" in the traditional sense of clinical or diagnostic studies. The "ground truth" for the non-clinical tests would be the accepted industry standards and methodologies for evaluating material and mechanical properties of medical devices.
Adjudication method for the test set:
- Not applicable. The listed performance data stems from non-clinical (benchtop) tests, not subjective interpretations requiring adjudication.
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 passive implant for bone fixation, not an AI-assisted diagnostic or interpretative tool. No MRMC study was performed.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm or software. Its performance is inherent to its material and design, evaluated through physical testing.
The type of ground truth used:
- For the non-clinical tests, the "ground truth" would be established by engineering standards and specifications for material properties and mechanical performance relevant to bone fixation devices. This includes, but is not limited to, industry standards, relevant ISO/ASTM guidelines, and internal company specifications derived from the intended use and predicate devices. There is no biological/clinical ground truth (e.g., pathology, outcomes data) as no clinical studies were performed.
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo for Biomet Manufacturing Corp. The logo is in black and white. The word "BIOMET" is in a stylized font, and the words "MANUFACTURING CORP." are below the logo in a smaller font.

K122770 Page 1/2

MAR 2 8 2013

510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

SUBMITTER INFORMATION
Name	Biomet Manufacturing Corp.
Address	56 East Bell DriveWarsaw, IN 46582
Phone number	(574) 267-6639
Fax number	(574) 371-1027
EstablishmentRegistration Number	1825034
Name of contact person	Patricia Sandborn BeresSenior Regulatory SpecialistBiomet Manufacturing Corp.
Date prepared	March 21, 2013
NAME OF DEVICE
Trade name	Biomet Reconstructive Wedges
Common name	Wedge
Classification name	Single/multiple component metallic bone fixation appliances andaccessoriesSmooth or threaded metallic bone fixation fastener
Classification panel	Orthopedics
Regulation	21 CFR 888.303021 CFR 888.3040
Product Code(s)	HRSHWC
Legally marketeddevice(s) to whichequivalence is claimed	Wright Medical Technology Inc.'s BIOFOAM® Bone Wedges clearedthrough the following 510(k)s: K070592, K073535 and K093950.
Reason for 510(k)submission	New device
Device description	Biomet Reconstructive Wedges are metallic blocks designed forinsertion into voids for alignment of bones in the foot or ankle.There are two styles of wedges which are oval and rectangular inshape. Wedges are available in a variety of widths, lengths andthicknesses. Rectangular cut-out windows allow the surgeon topack allograft within the device. The wedges are completelyporous, to allow for tissue ingrowth. There is a "skin" of solidtitanium on the outer edge of the component to facilitate theinsertion instrument and allow for identifying part marking to beadded to the devices.
Indications for use	Biomet Reconstructive Wedges are intended to be used for internalbone fixation for bone structures, fusions or osteotomies in the ankleand foot, such as:Open wedge osteotomies of Hallux Valgus Evans lengthening osteotomies Metatarsal/cuneiform arthrodesis
	Biomet Reconstructive Wedges are intended for use with ancillaryfixation.
	Biomet Reconstructive Wedges are not intended for use in the spine.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE
Biomet Reconstructive Wedges uses similar technology to the predicate BIOFOAM® Bone Wedge
Devices cleared through 510(k)s K070592, K073535, and K093950. The Biomet Reconstructive
Wedges are similar in material, design and sizing to the predicates.
PERFORMANCE DATA
Non-Clinical Tests Conducted For Determination Of Substantial Equivalence
Chemical Composition	Static Shear Strength
Static Compression Testing	Dynamic Compression Testing
Expulsion Testing	Compressive Strength
Porosity/Pore Size	Taber Abrasion
Interconnectivity	Roughness
Tensile Adhesion	MR Compatibility
Microstructure	Animal Data
Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical
Information
No clinical data submitted
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical data was necessary for a determination of substantial equivalence.
The results of testing indicated the material performed within the intended use, did not raise any new
safety and efficacy issues and were found to be substantially equivalent to the predicate devices.

Mailing Address, PO 30, 557 Warsa x 10 46581 0597 Toll Free &CD.348.95,00 C"ice 574 267 8639 14am Fax: 574 267 5137 now Dicmel Com

Shipping Address: 56 East Beat Onve Warsaw. IN 46532

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

. .

and the comments of the comments of

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 28, 2013

Biomet Manufacturing Corporation % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582

Re: K122770

Trade/Device Name: Biomet Reconstructive Wedges 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: February 18, 2013 Received: February 20, 2013

Dear Ms. Beres:

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

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

Page 2 - Ms. Patricia Sandborn Beres

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Ering of eith

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

Enclosure

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

Indications for Use

510(k) Number (if known):_____K1222770

Device Name: Biomet Reconstructive Wedges

Indications For Use:

Biomet Reconstructive Wedges are intended to be used for internal bone fixation for bone structures, fusions or osteotomies in the ankle and foot, such as:

Open wedge osteotomies of Hallux Valgus .
Evans lengthening osteotomies .
Metatarsal/cuneiform arthrodesis .

Biomet Reconstructive Wedges are intended for use with ancillary fixation.

Biomet Reconstructive Wedges are not intended for use in the spine.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth|崎原ank -S

Division of Orthopedic Devices

Page 1 of 1

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.