(184 days)
Acromed AcroPlate Anterior Cervical System, Codman Anterior Cervical Plate System, Aesculap Caspar Cervical Plate
Not Found
No
The summary describes a mechanical implant system (plates and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for use in the treatment of various conditions related to anterior cervical spine instability.
No
The device is described as an Anterior Compression Plate System used for treating cervical spine instability, not for diagnosing conditions. Its description focuses on its components and mechanical testing rather than diagnostic capabilities.
No
The device description explicitly states that the system consists of physical plates and screws made of Ti-6Al-4V, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The DePuy Motech PEAK™ Anterior Compression Plate System is a surgical implant used to stabilize the anterior cervical spine. It is a physical device implanted in the body to treat structural issues.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, based on the provided information, the DePuy Motech PEAK™ Anterior Compression Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Motech PEAK™ Anterior Compression Plate System is intended for use in the treatment of anterior cervical spine instability as a result of fractures, dislocations, subluxations, turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylosis or a previously failed cervical surgery.
Product codes
87 KWQ
Device Description
The DePuy Motech PEAK™ Anterior Compression Plate System consists of 12 different Ti-6Al-4V plates. The plates are available in 4 design segments (1, 2, 3 or 4 "I" shaped segments), each being available in 3 lengths. The system also includes Ti-6A1-4V 3.5mm cortical and 4.0mm cancellous screws in 13 lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior cervical spine
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)
Mechanical testing indicates that the fatigue strength of the DePuy Motech PEAK™ Anterior Compression Plate is similar to that of the Acromed AcroPlate and is adequate for it's intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Acromed AcroPlate Anterior Cervical System, Codman Anterior Cervical Plate System, Aesculap Caspar Cervical Plate
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 2 7 1996
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Cheryl Hastings
Manager, Clinical Affairs |
| TRADE NAME: | DePuy Motech PEAK™ Anterior Compression Plate System |
| COMMON NAME: | Anterior Cervical Plate |
| CLASSIFICATION: | 888.3060: Spinal intervertebral body fixation orthosis |
| PRODUCT CODE: | 87 KWQ |
| SUBSTANTIALLY | Acromed AcroPlate Anterior Cervical System
EQUIVALENT DEVICES: Codman Anterior Cervical Plate System
Aesculap Caspar Cervical Plate |
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Motech PEAK™ Anterior Compression Plate System consists of 12 different Ti-6Al-4V plates. The plates are available in 4 design segments (1, 2, 3 or 4 "I" shaped segments), each being available in 3 lengths. The system also includes Ti-6A1-4V 3.5mm cortical and 4.0mm cancellous screws in 13 lengths.
The DePuy Motech PEAK™ Anterior Compression Plate System is intended for use in the treatment of anterior cervical spine instability as a result of fractures, dislocations, subluxations, turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylosis or a previously failed cervical surgery.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Motech PEAK™ Anterior Compression Plate System is similar in material, design and intended use to the Acromed AcroPlate Anterior Cervical System, the Codman Anterior Cervical Plate System and the Aesculap Cervical Plate System. All of these systems consist of Ti-6Al-4V or CP Titanium bone plates and screws intended for anterior stabilization of the cervical spine. Mechanical testing indicates that the fatigue strength of the DePuy Motech PEAK™ Anterior Compression Plate is similar to that of the Acromed AcroPlate and is adequate for it's intended use.