(75 days)
Not Found
No
The device description and intended use clearly describe a mechanical plating and screw system for bone fixation, with no mention of software, algorithms, or any AI/ML related terms.
No.
The device is described as a plate and screw system for fixation of fractures, osteotomies, and non-unions, which is a structural implant for internal fixation, not a device that provides therapy for diseases or conditions.
No
The device is described as a plating system intended for fixation of fractures, osteotomies, and non-unions, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a titanium alloy plate and screw system, which are physical hardware components, 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 states the device is for the "fixation of fractures, osteotomies and non-unions" of various bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "titanium alloy (Ti-6Al-4V) plate and screw system." This is a physical implant used for internal fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The A.L.P.S. Small Fragment Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The 100 Degree Tubular Plate is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, distal tibia (including intra-articular), fibularly in osteopenic bone.
Washers are intended to be used in conjunction with bone screws.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTN
Device Description
The A.L.P.S.® Small Fragment System is a titanium alloy (Ti-6Al-4V) plate and screw system that fuses locking screw technology with conventional plating techniques.The subject device consists of plates, The devices are available in sterile and nonsterile options, and vary by sizes and number of holes, making the device suitable for a wide range of patient anatomy and needs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavice, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula
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)
Evaluation of MR compatibility to support MR Conditional labeling
-RF Heating- ASTM F2182
-Displacement Force- ASTM F2052
-Magnetic Torque- ASTM F2119
-Image Artifact- ASTM F2213
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K111663, K072083, K920738, K895107, K083843
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
February 19, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biomet Orthopedics Prerna Satavase Regulatory Affairs Sr Specialist 56 E Bell Drive Warsaw, Indiana 46581
Re: K243761
Trade/Device Name: A.L.P.S. Small Fragment 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, HTN, HWC Dated: December 6, 2024 Received: February 5, 2025
Dear Prerna Satavase:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, M.S. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
A.L.P.S. Small Fragment Plating System
Indications for Use (Describe)
The A.L.P.S. Small Fragment Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The 100 Degree Tubular Plate is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, distal tibia (including intra-articular), fibularly in osteopenic bone.
Washers are intended to be used in conjunction with bone screws.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) #: K243761
510(k) Summary
Prepared on: 2025-02-18
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Biomet Orthopedics | ||||
|---|---|---|---|---|---|
| Applicant Address | 56 E Bell Drive Warsaw IN 46581 United States | ||||
| Applicant Contact Telephone | +1 2605792510 | ||||
| Applicant Contact | Ms. Tracy Johnson | ||||
| Applicant Contact Email | tracy.johnson@zimmerbiomet.com | ||||
| Correspondent Name | Biomet Orthopedics | ||||
| Correspondent Address | 56 E Bell Drive Warsaw IN 46581 United States | ||||
| Correspondent Contact Telephone | +1 9095383506 | ||||
| Correspondent Contact | Ms. Prerna Satavase | ||||
| Correspondent Contact Email | prerna.satavase@zimmerbiomet.com | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | A.L.P.S. Small Fragment Plating System | ||||
| Common Name | Single/multiple component metallic bone fixation appliances and accessories | ||||
| Classification Name | Plate, Fixation, Bone | ||||
| Regulation Number | 888.3030 | ||||
| Product Code(s) | HRS, HWC, HTN | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | HRS | |||
| K072083 | SMALL FRAGMENT LOCKING PLATING SYSTEM | HRS | |||
| K920738 | ACE 100 DEGREES TUBULAR PLATE | HRS | |||
| K895107 | ACE ORTHOPAEDIC WASHERS | HTN | |||
| K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM | HRS | |||
| Device Description Summary | 21 CFR 807.92(a)(4) |
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The A.L.P.S.® Small Fragment System is a titanium alloy (Ti-6Al-4V) plate and screw system that fuses locking screw technology with conventional plating techniques.The subject device consists of plates, The devices are available in sterile and nonsterile options, and vary by sizes and number of holes, making the device suitable for a wide range of patient anatomy and needs.
Intended Use/Indications for Use
The A.L.P.S. Small Fragment Plating System is intended for fixation of fractures, ostectomies and non-unions of the clavice, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The 100 Degree Tubular Plate is intended for fixation of fractures and non-unions of the olecranon, humerus, radius, ulna, distal tibia (including intra-articular), fibula, particularly in osteopenic bone.
Washers are intended to be used in conjunction with bone screws.
Indications for Use Comparison
The indications are identical between the predicate and the subject device.
Technological Comparison
Comparison of Technological Characteristics:
The A.L.P.S. Small Fragment Plating System is similar in basic shape, material and performance characteristics to the predicate devices. There is no change in the fundamental scientific technology shared by both the subject device and predicate device and therefore the technological characteristics do not raise any different questions of safety and effectivenes.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Evaluation of MR compatibility to support MR Conditional labeling -RF Heating- ASTM F2182 -Displacement Force- ASTM F2052 -Magnetic Torque- ASTM F2119 -Image Artifact- ASTM F2213
Clinical data and conclusions were not needed for this device.
The proposed device has a similar intended use as the predicates and similar technological characteristics. The information provided herein demonstrates that:
• any differences do not raise any different questions of safety and effectiveness; and
· the proposed device is at least as safe and effective as the legally marketed predicate devices.
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)