(302 days)
The Latitud™ Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is an evidence of sufficient sound bone to fix and support the components.
Total hip replacement is indicated for the following conditions:
- · Non-inflammatory degenerative joint diseases including osteoarthritis, post-traumatic arthritis and avascular necrosis.
- · Rheumatoid arthritis.
- Congenital hip dysplasia.
- · Acute traumatic fracture of the femoral head or neck.
- · Certain cases of Ankylosis.
- Dislocation of the hip.
- · Correction of functional deformity.
- · Revision of failed joint reconstruction or treatment.
- · Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur.
Note:
- · The Titanium coated Modular Shell is intended for press-fit, uncemented use only.
- · The Hydroxyapatite coated Uncemented Femoral Stem is intended for press-fit, uncemented use only.
- · The Cemented Femoral stem is intended for cemented use only.
- The Modular Acetabular Liner is intended for use with Modular Acetabular Shell.
- · The CoCr Modular Femoral Head is intended to articulate with Modular Liner to mate with uncemented stem or cemented stem.
- The Biolox® delta Modular Femoral Head is intended to articulate with Modular Liner and to mate with uncemented stem or cemented stem.
- · The Bone Screw and Apical Hole Occluder are intended for use with Modular Acetabular shell.
- · The Centralizer and Cement Restrictor are intended for use with cemented stem only.
The Latitud™ Hip Replacement System consists of following components:
Acetabular Cup System
-
Modular Shell / Cup
-
Modular Liner
-
Cobalt Chromium Modular Femoral Head
-
Biolox® delta Modular Femeral Head
Femoral Stem -
Uncemented Femoral Stem
-
Cemented Femoral Stem
Accessories (Sub components) -
Bone Screw
-
Apical Hole Occluder
-
Centralizer
-
Cement Restrictor
Acetabular cup system is a modular acetabular replacement system consisting of a range of Modular Shells, Modular Liners, Cobalt chromium alloy and Biolox® delta Modular Femoral Heads. The Modular Shells are designed for use with dedicated sizes of Modular Liners articulating with a range of dedicated Cobalt chromium alloy and Biolox® delta Modular Femoral Heads.
Modular Shell: Modular Shell is intended for uncemented, press fit fixation with prepared acetabulum. They are designed for use with Modular liners. The Modular shell is fabricated from Ti-6Al-4V-ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Modular shell is available in different sizes. The outer surface of the Modular shell is coated with commercially pure Titanium. Two/Three screw holes are provided in Modular shell for additional immediate fixation with bone by means of Bone screws. A threaded apical hole is provided to attach instruments for surgical insertion. After fixation of Modular shell, apical hole will occlude by Occluder.
Modular Liner: Modular liner is designed to be used with Modular shell and articulate with a range of dedicated Cobalt chromium alloy or Biolox® delta Modular femoral heads. Modular liner is fabricated from Highly Cross-Linked Polyethylene (HXLPE). It is available in different sizes.
Cobalt chromium Modular Femoral Head: Modular femoral head fabricated from cobalt chromium alloy is designed to mate with 12/14 taper of femoral stem through taper-locking arrangement and to articulate with Modular liner. It is available in different sizes with different offsets.
Biolox® Delta Modular Femoral Head: Modular femoral head fabricated from ceramic material (Biolox® delta, by CeramTec. Germany) is designed to mate with 12/14 taper of femoral stem through taper-locking arrangement and to articulate with Modular liner. It is available in different sizes with different offsets.
Uncemented Femoral Stem: The Uncemented femoral stem is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). It has 12/14 taper at the top which mates with Cobalt chromium alloy and Biolox® delta Modular femoral head. This stem is implanted without use of bone cement. Stem is coated with Hydroxyapatite (HA) by plasma spraying method. These stems are available in different sizes with three different neck angles. Uncemented femoral stem is intended for press-fit uncemented use only.
Cemented Femoral Stem: Cemented femoral stem is fabricated from High Nitrogen Stainless Steel (HNSS). It has 12/14 taper trunnion at the top which mates with Cobalt chromium alloy and Biolox® delta Modular femoral head. This stem is implanted with use of bone cement. These stems are available in different sizes with two different offsets. Cemented stem is intended for cemented use only.
Accessories (Subcomponents):
Bone Screw: Bone screw is used if additional fixation of Modular shell is required. Bone screw is self tapping and is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Bone screw is available in 6.5 mm diameter with different lengths.
Apical Hole Occluder: Apical hole occluder is provided to occlude the apical hole after fixation of the Modular shell in acetabulum. Apical hole occluder is fabricated from Titanium alloy - ELI (Titanium-6Aluminum-4Vanadium Extra Low Interstitial). Apical hole occluder is available in one size.
Centralizer: Centralizer is used for correct positioning of Cemented stem in medullary canal of femur. Centralizer is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE). Centralizer is designed to be used with Cemented stem only. Centralizer is offered in two sizes.
Cement Restrictor: Cement restrictor is used to occlude and seal intramedullary canal in order to generate sufficient pressure to enhance cement penetration and to prevent distal cement leakage. Cement restrictor is designed to be used with Cemented stem only. Cement restrictor is fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE). Cement restrictor is provided in two sizes.
The provided text is a 510(k) Summary for the Latitud™ Hip Replacement System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance testing, rather than presenting a clinical study with acceptance criteria and device performance as one might find for a novel diagnostic or therapeutic device.
Therefore, the requested information elements related to clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.
However, I can extract information related to the non-clinical performance data and the conclusion on substantial equivalence.
Here's the relevant information that can be extracted:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established by the referenced ASTM and ISO standards for mechanical testing of orthopedic implants. The document states that the system "was subjected to following nonclinical performance testing to evaluate device function/mechanical performance." The implication is that the device met the requirements of these standards. Specific numerical acceptance criteria and precise performance values are not detailed in this summary; rather, the successful completion of these tests serves as the proof of meeting criteria for substantial equivalence.
| Acceptance Criteria Category (as per referenced standard) | Reported Device Performance (Implied by successful testing) |
|---|---|
| Material/Component Properties: | |
| Ti coating adhesion (shear) (ASTM F1044-05) | Met requirements of ASTM F1044-05 |
| HA coating adhesion (shear) (ASTM F1044-05) | Met requirements of ASTM F1044-05 |
| Bone Screw Torsion properties (ASTM F543-13e) | Met requirements of ASTM F543-13e |
| Bone Screw Pull out properties (ASTM F543-13e) | Met requirements of ASTM F543-13e |
| Bone Screw Driving torque test (ASTM F543-13e) | Met requirements of ASTM F543-13e |
| Bone Screw Self tapping performance (ASTM F543-13e) | Met requirements of ASTM F543-13e |
| Acetabular Cup System Performance: | |
| Axial Disassembly (Push out) (ASTM F1820-2013) | Met requirements of ASTM F1820-2013 |
| Offset pull out (Lever Out) (ASTM F1820-2013) | Met requirements of ASTM F1820-2013 |
| Torque Out Disassembly (ASTM F1820-2013) | Met requirements of ASTM F1820-2013 |
| Wear test (ISO 14242-3-2009 & ISO 14242-2-2014) | Met requirements of ISO 14242-3-2009 & ISO 14242-2-2014 |
| Impingement test (ASTM F2582-14) | Met requirements of ASTM F2582-14 |
| Burst test, Fatigue test, Post fatigue burst test, Pull-off test for Biolox® delta Modular femoral head and Uncemented Femoral Stem (ISO 7206-10) | Met requirements of ISO 7206-10 |
| Torque test for Biolox® delta Modular Femoral head (ASTM F1820) / Torsional resistance test (ISO 7206-13) | Met requirements of ASTM F1820 / ISO 7206-13 |
| Burst test for Biolox® delta Modular femoral head and Cemented Femoral Stem | Met requirements (standard not explicitly stated for this specific test) |
| Femoral Stem Performance: | |
| Fretting Corrosion (ASTM F1875-98) (Uncem. & Cem. Stems) | Met requirements of ASTM F1875-98 |
| Axial pull-off test (ISO 7206-10-2003) (Uncem. & Cem. Stems) | Met requirements of ISO 7206-10-2003 |
| Proximal fatigue test (ISO 7206-6-2013) (Uncem. & Cem. Stems) | Met requirements of ISO 7206-6-2013 |
| Distal fatigue test (ISO 7206-4-2010) (Uncem. & Cem. Stems) | Met requirements of ISO 7206-4-2010 |
| System Level Performance: | |
| Range of motion test (ISO 21535-2007) | Met requirements of ISO 21535-2007 |
| Endotoxin testing (USP sterility & Endotoxin) | Demonstrated manufacturing process does not introduce Endotoxin, confirmed by 14-day USP sterility testing and USP Endotoxin testing prior to release. |
1. A table of acceptance criteria and the reported device performance
See table above. The "reported device performance" is implied by the statement "subjected to following nonclinical performance testing to evaluate device function/mechanical performance" and the overall conclusion of substantial equivalence. For 510(k) submissions based on mechanical testing, specific numerical results are often contained in the full submission, but the summary confirms successful completion against established standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the summary document. Mechanical testing for these types of devices typically involves a specified number of samples per test condition as dictated by the respective ASTM/ISO standards.
- Data Provenance: Not explicitly stated as "country of origin of the data." The applicant is Meril Healthcare Private Limited, based in Gujarat, INDIA. The testing was non-clinical (laboratory/mechanical testing), not human data.
- Retrospective or Prospective: Not applicable, as this is non-clinical performance data (material and mechanical testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a 510(k) for an orthopedic implant, where "ground truth" is established by adherence to recognized mechanical and materials testing standards, not by expert medical interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This describes non-clinical testing, not a clinical study requiring adjudication of expert opinions.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a 510(k) for an orthopedic implant, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) for an orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission are the established specifications and performance requirements outlined in the referenced ASTM and ISO consensus standards for orthopedic implants. Successful demonstration of meeting these standards through mechanical and material testing serves as the basis for substantial equivalence.
8. The sample size for the training set
Not applicable. This is a 510(k) for an orthopedic implant based on non-clinical performance and substantial equivalence to predicate devices, not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.