(86 days)
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Not Found
No
The description focuses on the mechanical design and function of a surgical implant and its associated instruments, with no mention of AI or ML capabilities.
No
The device is described as assisting in the reattachment of the greater trochanter and providing fixation, which are structural and mechanical functions, not therapeutic.
No
The device is described as a reattachment device for stabilizing the greater trochanter after osteotomy or fracture, and its description focuses on its mechanical function and components, not on diagnosing medical conditions.
No
The device description clearly outlines a physical implant (stabilizer, cables, instruments) used for surgical reattachment, not a software application.
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 surgical device used for the reattachment of the greater trochanter following osteotomy or fracture. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a physical implant (stabilizer and cables) and instruments for surgical fixation. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, 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 for structural repair.
N/A
Intended Use / Indications for Use
The GTR Device is used for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally, the device is used to reattach the greater trochanter following fracture of the greater trochanter.
Product codes
CFR 888.3010
Device Description
The Pioneer Greater trochanteric Reattachment Device (GTR) is a low profile, ovaloid stabilizer combined with multifilament cables are affixed to the ovaloid stabilizer and serve to attach the device to the trochanter providing fixation. Instruments that tension and lock the cable are provided with the GTR system. The GTR is offered in two (2) styles.
The GTR stabilizer is designed with proximal fingers which hook over the top of the proximal osteotomized trochanter and serve to position the device during fixation and apply a distal force after fixation. The extended version incorporates a distal plate stem.
The cables are affixed to the GTR unit are passed around or through the femur and back into the GTR Device. The ovaloid GTR unit is placed on the osteotomized trochanter which is then positioned on the femur. Proper tensioning is applied to the cables with a tensioning instrument. The cables are then locked in place by tightening a screw which crimps a sleeve and cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
greater trochanter, femur
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)
The Pioneer Laboratories device was predicated on the use of stainless steel wire and the Dall-Miles Cable Grip System. All three systems were tested in static and fatigue loadings. Both the Pioneer and Dall-Miles Greater Trochanteric Reattachment Devices exceeded the static and fatigue values obtained by wire systems. Additionally, values obtained indicate the Pioneer GTR equaled or was greater than Dall-Miles.
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.
Dall-Miles Trochanter Cable Grip manufactured by Howmedica
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
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
K96/267
JU 27 M
PIONEER LABORATORIES 510(K) NOTIFICATION SUMMARY for GTR (Greater Trochanteric Reattachment) DEVICE
GTR (Greater Trochanteric Reattachment), DLV
ADMINISTRATIVE INFORMATION
Manufacturer Identification and Sponsor:
Pioneer Laboratories 375 River Park Circle Marquette, MI 49855 Phone (906)226-9909 FAX (906)226-9932
Official Contact:
Steve Severson Vice President, Regulatory Affairs/Quality Assurance
Date Prepared: 3/26/96
DEVICE DENTIFICATION
Proprietary Name:
Pioneer System GTR (Greater Trochanter Reattachment) Device
Classification Name:
Cerclage, Bone Fixation CFR 888.3010
Device on which substantial equivalence is claimed:
Dall-Miles Trochanter Cable Grip manufactured by Howmedica
1
GTR 510(k) Summary Establishment Registration Number: 1833824 Page 2
DEVICE DESCRIPTION
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
The Pioneer Greater trochanteric Reattachment Device (GTR) is a low profile, ovaloid stabilizer combined with multifilament cables are affixed to the ovaloid stabilizer and serve to attach the device to the trochanter providing fixation. Instruments that tension and lock the cable are provided with the GTR system. The GTR is offered in two (2) styles.
The GTR stabilizer is designed with proximal fingers which hook over the top of the proximal osteotomized trochanter and serve to position the device during fixation and apply a distal force after fixation. The extended version incorporates a distal plate stem.
The cables are affixed to the GTR unit are passed around or through the femur and back into the GTR Device. The ovaloid GTR unit is placed on the osteotomized trochanter which is then positioned on the femur. Proper tensioning is applied to the cables with a tensioning instrument. The cables are then locked in place by tightening a screw which crimps a sleeve and cable.
INTENDED USE
The GTR Device is used for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally, the device is used to reattach the greater trochanter following fracture of the greater trochanter.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE
Both devices utilize cable which holds the device and anchors the trochanter. The cables are crimped into place. The Dall-Miles device utilizes a crimping tool whereas the Pioneer device uses a screw.
The Dall-Miles device is H-shaped whereas the Pioneer device is oval. Both use proximal hooks for the top of the osteotomized trochanter. Both offer cobalt chrome cable. The Pioneer device is made of titanium-the Dall-Miles cobalt chrome.
2
GTR 510(k) Summary Establishment Registration Number: 1833824 Page 3
PERFORMANCE DATA
100
The Pioneer Laboratories device was predicated on the use of stainless steel wire and the Dall-Miles Cable Grip System. All three systems were tested in static and fatigue loadings. Both the Pioneer and Dall-Miles Greater Trochanteric Reattachment Devices exceeded the static and fatigue values obtained by wire systems. Additionally, values obtained indicate the Pioneer GTR equaled or was greater than Dall-Miles.