(127 days)
Not Found
No
The summary describes a mechanical implant (plate and screws) for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the stabilization and fixation of fractures, fusions, and reconstructions of bones, which are therapeutic interventions.
No
The device is described as an implantable plate system used for stabilization and fixation of fractures and reconstructive surgeries, not for diagnosing conditions.
No
The device description clearly states it is a "2.5mm Titanium alloy fusion plate" and includes "non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr," indicating it is a physical implant and associated hardware, 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 a device for the stabilization and fixation of bones during surgical procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a plate and screws made of titanium alloy and CoCr, used for bone fixation. This is consistent with a surgical implant, not a device used to test samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to physically support and stabilize bones.
N/A
Intended Use / Indications for Use
The system is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
Product codes
HRS
Device Description
The ALPS 2.5mm Inline Fusion Plate consists of a 2.5mm Titanium alloy fusion plate offered to be used with non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures, fusions, revisions and reconstructive surgeries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis
Indicated Patient Age Range
adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
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)
No new issues of safety or efficacy have been raised.
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
Section 5 — 510(k) Summary
| Submitted by: | Biomet Trauma
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Phone: (305) 269-6386
Fax: (305) 269-6400
OCT 2 9 2013 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Suzana Otaño, Global Project Manager, Regulatory Affairs |
| Date Prepared: | June 17, 2013 |
| Proprietary Name: | ALPS 2.5mm Inline Fusion Plate |
| Common Name: | Plate, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances and
accessories (21 CFR § 888.3030) |
| Predicate Devices: | The ALPS 2.5mm Inline Fusion Plate is substantially equivalent to
currently marketed Fracture and Fusion Plating System (K093474)
and the Mini Fragment Plating System (K061748). |
| Device Description: | The ALPS 2.5mm Inline Fusion Plate consists of a 2.5mm Titanium
alloy fusion plate offered to be used with non-locking, locking and
variable angle screws manufactured from Titanium alloy and CoCr
for bone fixation and the management of fractures, fusions,
revisions and reconstructive surgeries. |
| Indications for Use: | The system is intended for use in stabilization and fixation of
fractures, revision procedures, fusions, reconstructions (osteotomy)
and non-unions of the bones of the hand, foot, wrist, ankle, finger,
toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in
osteopenic bone. The system can be used in both adult and
pediatric patients (adolescents [>12 - 21 years of age]), where the
implant would not cross open epiphyseal plates in skeletally
immature patients. |
| Technological
Characteristics: | The technological characteristics of the ALPS 2.5mm Inline Fusion
Plate are similar to the predicate devices including design,
dimensions and material. |
:
·
Page 46 of 232
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K131867 page 1 of 2
Summary of Substantial Equivalence:
The ALPS 2.5mm Inline Fusion Plate is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data including axial load construct testing and evaluation of galvanic corrosion potential. No new issues of safety or efficacy have been raised.
ALPS 2.5mm Inline Fusion Plate - Traditional 510(k) - Amended Biomet Trauma
Page 47 of 232
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol to the right, consisting of three curved lines that resemble a human form. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 29, 2013
Biomet, Inc. Ms. Suzana Otaño Global Project Manager, Regulatory Affairs 56 East Bell Drive P.O. Box 587 Warsaw. Indiana 46581
Re: K131867
Trade/Device Name: ALPS 2.5mm Inline Fusion Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Date: September 30, 2013 Received: October 1. 2013
Dear Ms. Otaño:
We have reviewed vour 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
3
Page 2 - Ms. Suzana Otaño
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 (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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ering Meith
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: | K131867 |
|---|---|
| Device Name: | ALPS 2.5mm Inline Fusion Plate |
Indications For Use:
Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
× 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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