(71 days)
K 872224, K 900926
K 872224
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related concepts in the provided text.
Yes
The device is described as providing "trochanteric reattachment following osteotomy in Total Hip Arthroplasty," which indicates it is used for the treatment or management of a medical condition.
No
The device is described as a surgical implant (Grip component) used for reattachment of the trochanter, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical "Grip component" and "Dall-Miles cables" which are hardware used in a surgical procedure. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "trochanteric reattachment following osteotomy in Total Hip Arthroplasty." This is a surgical procedure performed in vivo (within the body).
- Device Description: The description details a mechanical component used to secure bone fragments during surgery. It does not involve analyzing biological samples (like blood, urine, or tissue) in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on analysis of biological samples.
The device is clearly an implantable surgical device used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Dall-Miles Trochanter Cable Grip described in this submission is a modification of the original Dall-Miles Cable Grip cleared in (K 872224). The Grip component provides for trochanteric reattachment following osteotomy in Total Hip Arthroplasty.
Product codes
OR(87) JDQ
Device Description
The Dall-Miles Trochanter Cable Grip described in this submission is a modification of the original Dall-Miles Cable Grip cleared in (K 872224). The Grip component provides for trochanteric reattachment following osteotomy in Total Hip Arthroplasty. The proximal hooks of the Grip are placed over the top of the trochanter and secured by passing Dall-Miles cables through the holes and crimping them in place.
The modification to the Grip reduces the angle that the cable exits the Grip, thereby relieving potential stress concentrations in the cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trochanteric
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K 872224, K 900926
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
R 18 8 16
510 (k) Summary
Proprietary Name: Dall-Miles Trochanter Cable SuperGrip
Common Name: Bone Fixation Cerclage
j
Classification Name and Reference: Bone Fixation Cerclage 21 CFR 888.3010
Proposed Regulatory Class: Class II Device Product Code: OR(87) JDQ
For information contact: Frank Maas
Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 6/3/96
The Dall-Miles Trochanter Cable Grip described in this submission is a modification of the original Dall-Miles Cable Grip cleared in (K 872224). The Grip component provides for trochanteric reattachment following osteotomy in Total Hip Arthroplasty. The proximal hooks of the Grip are placed over the top of the trochanter and secured by passing Dall-Miles cables through the holes and crimping them in place.
The modification to the Grip reduces the angle that the cable exits the Grip, thereby relieving potential stress concentrations in the cable.
The substantial equivalence of the Dall-Miles Trochanter Cable Grip is based on the equivalence in intended use, materials, design, operational principles, and indications and contraindications to Howmedica's original Dall-Miles Cable Grip System (K 872224 and K 900926) and Biomet Medical Products' BMP Cable System.