(199 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and material composition of the bone wedges, with no mention of AI or ML.
Yes
The device is described as an internal bone fixation device used for bone structures, fusions, or osteotomies in the ankle and foot, which directly treats or alleviates a medical condition.
No
Explanation: The device is a wedge used for internal bone fixation and alignment, not for diagnosing medical conditions.
No
The device description clearly states that the device is a metallic block designed for insertion into voids for alignment of bones, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for internal bone fixation during surgical procedures in the ankle and foot. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a metallic block designed for insertion into bone voids. This aligns with a surgical implant, not an in vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Biomet Reconstructive Wedges are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
HRS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle and foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
No clinical data submitted
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 Drive |
| Warsaw, IN 46582 | |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| Establishment | |
| Registration Number | 1825034 |
| Name of contact person | Patricia Sandborn Beres |
| Senior Regulatory Specialist | |
| Biomet 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 and |
| accessories | |
| Smooth or threaded metallic bone fixation fastener | |
| Classification panel | Orthopedics |
| Regulation | 21 CFR 888.3030 |
| 21 CFR 888.3040 | |
| Product Code(s) | HRS |
| HWC | |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | Wright Medical Technology Inc.'s BIOFOAM® Bone Wedges cleared |
| through 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 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. | |
| 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. | |
| 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
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and the comments of the comments of
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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
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