(167 days)
The METS® Modular Distal Femur is intended for the replacement of diseased or deficient bone in the distal femur. It is indicated for:
Limb salvage procedures where radical resection and replacement of the bone is required
Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies.
Tumor resections
Revision of previously failed total joint arthroplasty
Trauma
The METS® Modular Distal Femur and its components are for single use only.
The METS® Modular Distal Femur and its components are for cemented use only.
The single use METS® Modular Distal Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the distal femur. The stems of the system are intended for cemented use only. The system comprises a range of stems, collars hydroxyapatite (HA) coated or without, (stippled or smooth), a range of shafts, femoral component (including axle, bushes and circlip), bumper and the SMILES knee (available in 3 types of arrangements, and in a rotating or fixed configuration).
The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).
This document is a 510(k) premarket notification for a medical device called the METS® Modular Distal Femur. It provides information to demonstrate substantial equivalence to previously marketed devices, rather than establishing acceptance criteria or reporting on a study that proves the device meets specific performance criteria in the way envisioned by the prompt.
Therefore, the requested information elements related to acceptance criteria, device performance, study design, ground truth, and expert evaluation are not applicable or not available within this type of regulatory submission.
This submission focuses on non-clinical performance and a clinical evaluation based on existing literature and post-market surveillance of predicate devices.
Here's why each specific requested item is not found:
- A table of acceptance criteria and the reported device performance: This document does not establish new acceptance criteria or report performance against them in a comparative study. Instead, it asserts substantial equivalence by comparing the device's characteristics and non-clinical testing results to predicate devices.
- Sample size used for the test set and the data provenance: There is no "test set" in the context of a prospective clinical study with a specific sample size. The clinical evaluation relies on previously published papers and post-market surveillance of predicate devices.
- Number of experts used and qualifications: Not applicable. There's no expert ground truth establishment for a specific test set.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not a study assessing human reader improvement with AI assistance.
- Standalone (algorithm only) performance: Not applicable. This device is a modular orthopedic implant, not an algorithm.
- Type of ground truth used: Not applicable in the context of a new clinical study. The clinical performance conclusions are drawn from published papers and post-market surveillance of predicate devices, which would have their own forms of "ground truth" established during their original studies (e.g., patient outcomes, radiographic evaluation).
- Sample size for the training set: Not applicable. There is no AI algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
However, this document does describe "Performance Data: (non-clinical and clinical)".
Here's a summary of the available information regarding performance:
1. Table of "Acceptance Criteria" (as implied by equivalence to predicates) and Reported Performance:
| Implied "Acceptance Criteria" (via substantial equivalence) | Reported Device Performance |
|---|---|
| Non-Clinical Testing: | |
| Knee fatigue and wear test | Results demonstrate the device is safe, effective, and substantially equivalent to predicates. |
| Disassembly force testing for taper connections | |
| ASTM F1800-07 testing | |
| Clinical Performance: | |
| Equivalence to predicate devices in: | Clinical evaluation based on published papers and post-market surveillance concludes substantial equivalence. |
| - Intended Use | |
| - Indications for Use | |
| - Design/technological characteristics | |
| - Materials of composition | |
| - Method of sterilization | |
| - Performance data (non-clinical) | |
| - Clinical evaluation |
2. Sample size used for the test set and the data provenance:
- Non-clinical testing: No specific sample sizes are provided for the knee fatigue, wear, disassembly force, or ASTM F1800-07 tests.
- Clinical evaluation: No specific "test set" or sample size for a prospective study is mentioned. The clinical evaluation was "carried out based upon published papers and post market surveillance" related to predicate devices. The provenance of this data would be from the original studies and post-market reports related to the predicate devices (K092138, K002757, K023087, K021489).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The clinical evaluation reviews existing literature rather than establishing new ground truth with experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards met. For the clinical evaluation, it relies on the "ground truth" established in the published papers and post-market surveillance of the predicate devices. This would typically include patient outcomes data, surgeon assessments, radiographic evaluations, and complication rates.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.
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长121029
SEP 1 9 2012
. "
SECTION 5: 510(k) SUMMARY
| Preparation Date | 7th September 2012 |
|---|---|
| Trade Name: | METS® MODULAR DISTAL FEMUR |
| Common Name: | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Classification Name: | Knee joint femorotibial metal/polymer constrained cemented prosthesis (21 CFR 888.3510, Product Code KRO) |
| Applicant/Sponsor: | Stanmore Implants Worldwide Ltd210 Centennial AvenueCentennial ParkElstreeWD6 3SJPhone: + 44 (0) 20 8238 6503Facsimile: +44 (0) 20 8954 0351 |
| Contact Person: | Nancy MacDonaldManager of Regulatory AffairsHealth Policy Associates Inc.Email: nmacdonald@healthpolicyassociates.comTel: (781) 329-2993Fax: (781) 329-2958 |
| Equivalent to: | JTŞ Extendible Implant, Stanmore Implants (K092138)Orthopaedic Salvage System (OSS) Biomet (K002757) GlobalModular Replacement System (GMRS) Howmedica (Stryker)(K023087) and the Repiphysis Limb Salvage System WrightMedical (K021489) |
| Device Description: | The single use METS® Modular Distal Femur is a standardmodular system that is intended for the replacement of diseased ordeficient bone in the distal femur. The stems of the system areintended for cemented use only. The system comprises a range ofstems, collars hydroxyapatite (HA) coated or without, (stippled orsmooth), a range of shafts, femoral component (including axle,bushes and circlip), bumper and the SMILES knee (available in 3types of arrangements, and in a rotating or fixed configuration).The materials used in the manufacture of the systems includetitanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultrahigh molecular weight polyethylene (UHMWPE). |
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Intended Use:
Indications for Use:
The METS® Modular Distal Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Limb salvage procedures where radical resection and replacement of the bone is required
Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies
Tumor resections
Treatment of non-unions, femoral neck and trochanteric fracture of the distal femur with head involvement, unmanageable using other techniques
Revision of previously failed total joint arthroplasty Trauma
The METS® Modular Distal Femur and its components are for single use only.
The METS® Modular Distall Femur and its components are for cemented use only.
Performance Data: (non-clinical and
clinical)
Substantial Equivalence: Non Clinical Testing
The results of the non-clinical performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate devices. The Performance testing included: knee fatigue and wear test, disassembly force testing for the taper connections, ASTM F1800-07 testing.
Clinical Performance Conclusions
Clinical evaluation was carried out based upon published papers and post market surveillance.
The METS® Modular Distal Femur is equivalent to the JTS Extendible Implant (K092138); Biomet OSS (K002757); the Howmedica (Stryker) GMRS (K023087) and the Repiphysis Limb Salvage System (K021489) predicate devices. The determination of substantial equivalence is based on the similarity of the intended use, indications for use, design/ technological characteristics, materials of composition, method of sterilization, performance data and clinical evaluation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a bird or eagle in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 9 2012
Stanmore Implant Worldwide, Ltd. % Ms. Nancy MacDonald Manager, Regulatory Affairs Health Policy Associates, Inc. 690 Canton Street Suite 302 Westwood, Massachusetts 02090
Re: K121029
Trade/Device Name: METS Modular Distal Femur Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO Dated: September 7, 2012 Received: September 10, 2012
Dear Ms. MacDonald:
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 (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. 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r was of a 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
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Page 2 - Ms. Nancy MacDonald
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
< 121029
Device Name:
METS® MODULAR DISTAL FEMUR.
Indications for Use:
The METS® Modular Distal Femur is intended for the replacement of diseased or deficient bone in the distal femur. It is indicated for:
Limb salvage procedures where radical resection and replacement of the bone is required Painful and disabled joint resulting from avascular necrosis osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies.
Tumor resections
Revision of previously failed total joint arthroplasty
Trauma
The METS® Modular Distal Femur and its components are for single use only.
The METS® Modular Distal Femur and its components are for cemented use only.
Ashb
(Division Sign-Oft) Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K121029
X Prescription Use (Per 21 CFR 801 Subpart D) AND/ OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.