(64 days)
No
The device description and performance studies focus on mechanical properties and surgical fixation, with no mention of AI/ML terms or functionalities.
Yes
The device is described as a "series of bone plates and screws intended to stabilize calcaneal fractures," which directly addresses a pathological condition (fractures) and aims to restore proper anatomical function, aligning with the definition of a therapeutic device.
No
Explanation: The device is described as a plating system intended for fixation of fractures, fusions, and osteotomies of the calcaneus, indicating a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description explicitly states it is a "series of bone plates and screws," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of fractures, fusions, and osteotomies of the calcaneus." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "bone plates and screws intended to stabilize calcaneal fractures." These are physical implants used in surgery.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The information provided clearly indicates this is a surgical implant used for orthopedic procedures, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Biomet A.L.P.S Calcaneal Plating System is intended for fixation of fractures, fusions, and osteotomies of the calcaneus.
Product codes
HRS
Device Description
The new A.L.P.S calcaneal plating system is a series of bone plates and screws intended to stabilize calcaneal fractures. The plates come in a left and right specific MIS configuration with five size options and left and right MESH configuration that is offered in three sizes. The plates are manufactured from titanium (ASTM F136) and will utilize the legally marketed and predicate A.L.P.S screw system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calcaneus
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)
Preclinical performance tests/rationales were provided to address the subject construct's strength. Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DePuy Fracture and Fusion Plating System (K093474), DePuy Calcaneal Plate (K993465), Tornier Calcaneal Fracture Plate System (K090582)
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.
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K132898 page 1 of 2
Section 5 - 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 |
| P.O. Box 587 | |
| Warsaw, IN 46581-0857 | |
| Phone number | (574) 372-1941 |
| Fax number | (574) 371-1027 |
| Establishment | |
| Registration Number | 1825034 |
| Name of contact | |
| person | Jared Cooper |
| Regulatory Affairs Specialist | |
| Date prepared | 09/06/13 |
| Name of device | |
| Trade or proprietary | |
| name | A.L.P.S Calcaneal Plating System |
| Common or usual | |
| name | Bone Fixation Plate |
| Classification name | Single/multiple component metallic bone fixation appliances and |
| accessories (21 CFR § 888.3030) | |
| Classification panel | Orthopedics |
| Regulation | 21 CFR § 888.3030 |
| Product Code(s) | HRS - Plate, Fixation, Bone: Single/multiple |
| component metallic bone fixation appliances and | |
| accessories | |
| Legally marketed device(s) to | |
| which equivalence is claimed | DePuy Fracture and Fusion Plating System (K093474), |
| DePuy Calcaneal Plate (K993465), | |
| Tornier Calcaneal Fracture Plate System (K090582) | |
| Reason for 510(k) submission | New Device Construct |
| Device description | The new A.L.P.S calcaneal plating system is a series of bone plates |
| and screws intended to stabilize calcaneal fractures. The plates | |
| come in a left and right specific MIS configuration with five size | |
| options and left and right MESH configuration that is offered in | |
| three sizes. The plates are manufactured from titanium (ASTM | |
| F136) and will utilize the legally marketed and predicate A.L.P.S | |
| screw system. | |
| Indications for use | The Biomet A.L.P.S Calcaneal Plating System is intended for fixation |
| of fractures, fusions, and osteotomies of the calcaneus. | |
| Summary of the Technologies |
The technological characteristics of the A.L.P.S calcaneal plating system are similar to the predicate devices including design, dimensions and material.
i
1
PERFORMANCE DATA SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Performance Test Summary-New Device
ッシュ・
The A.L.P.S Calcaneal Plating System components have the same basic technological and material characteristics as the predicate devices except for slight modifications to the general design as described in this 510(k) notification. Preclinical performance tests/rationales were provided to address the subject construct's strength. Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of preclinical tests/engineering rationales and the similarities with legally marketed devices indicate ALPS calcaneal plating System is substantially equivalent to currently marketed devices. No new issues of safety or efficacy have been raised.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2013
Biomet Manufacturing Corporation Mr. Jared Cooper Regulatory Affairs Specialist P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46581-0857
Re: K132898
Trade/Device Name: A.L.P.S Calcaneal Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: October 1, 2013 Received: October 2, 2013
Dear Mr. Cooper:
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. Ilsting 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 - Mr. Jared Cooper
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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 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.
Lori A: Wiggins
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use Statement
510(k) Number: K132898
A.L.P.S Calcaneal Plating System Device Name:
Indications For Use:
The Biomet A.L.P.S Calcaneal Plating System is intended for fixation of fractures, fusions, and osteotomies of the calcaneus.
× Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR Over-the-Counter_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
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