(287 days)
The Patient Specific 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 resection Revision of previously failed total joint arthroplasty Trauma
The Patient Specific Distal Femur and its components are for single use only.
The Patient Specific Distal Femur and is components are for cemented use only.
The Patient Specific Distal Femur is a patient-specific system that is intended for the replacement of diseased or deficient bone in the distal femur. The Patient Specific Distal Femur and its components are intended for cemented use only. The system is comprised of a range of stems, collars coated with hydroxyappetite (HA) or without coating (stippled or smooth), a range of shafts, femoral components (including axle, bushes and circlip), bumpers and a femoral epiphysis component, (i.e. SMILES TKR).
The materials used in the manufacture of the Patient Specific Distal Femur include titanium alloy (Ti-6Al-4V), cobalt-chromium-molybdenum (Co-Cr-Mo) and ultra-high molecular weight polyethylene (UHMWPE).
The device is for single use only.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "Patient Specific Distal Femur." It is a regulatory approval document and, as such, does not contain the detailed study information typically found in a scientific paper or clinical trial report.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Disassembly of the distal femur | Met acceptance criteria |
| Fatigue testing of the knee | Met acceptance criteria |
| Wearing testing of the knee | Met acceptance criteria |
Explanation: The document states, "The Patient Specific Distal Femur has been evaluated through non-clinical performance testing for disassembly of the distal femur and fatigue and wearing testing of the knee. The Patient Specific Distal Femur met all of the acceptance criteria." However, it does not specify what those acceptance criteria were (e.g., specific load endurance limits, wear rates, etc.). It only confirms that the device passed them.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. This document only mentions "non-clinical performance testing," which implies mechanical or lab testing, not human subjects.
- Data Provenance: Not applicable for non-clinical testing in terms of geographic origin or retrospective/prospective human data. The testing was conducted on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the document refers to "non-clinical performance testing" (mechanical/lab testing), not an assessment requiring expert clinical judgment for ground truth.
4. Adjudication method for the test set:
- Not applicable for non-clinical performance testing. Adjudication methods like 2+1 or 3+1 typically apply to human reader studies where there's a need to resolve discrepancies in 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:
- No, an MRMC study was not done. This device is a physical medical implant (a knee prosthesis), not an AI diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the non-clinical performance tests mentioned (disassembly, fatigue, wearing), the "ground truth" would be established by engineering standards and specifications for mechanical integrity, durability, and biocompatibility. The document does not explicitly state these standards but implies their use by mentioning "acceptance criteria."
8. The sample size for the training set:
- Not applicable. This device is a physical implant, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for this type of device.
Summary of what the document focuses on:
The entire document pertains to a 510(k) submission, which aims to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device. This is primarily established through comparisons of:
- Intended Use
- Technological Characteristics
- Materials
- Non-clinical performance data (as briefly summarized here)
The "Performance Data" section in this 510(k) is very concise and only states that the device "met all of the acceptance criteria" for the mentioned non-clinical tests. It doesn't provide the detailed methodology, specific acceptance values, or raw results of these tests, which would typically be found in a more comprehensive study report. This level of detail is usually reviewed by the FDA but not always included in the publicly available summary letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2015
Stanmore Worldwide Implants, Ltd. Mr. Dan Clarke Regulatory and Compliance Officer 210 Centennial Avenue Centennial Park Elstree WD6 3SJ United Kingdom
Re: K140898
Trade/Device Name: Patient Specific Distal Femur Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: December 19, 2014 Received: December 22, 2014
Dear Mr. Clarke:
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 that FDA 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 comply with all the Act's requirements, including, but not limited to: registration and listing
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Page 2 - Mr. Dan Clarke
(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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number: | K140898 |
|---|---|
| Device Name: | Patient Specific Distal Femur |
| Indications for Use: | The Patient Specific 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 resection Revision of previously failed total joint arthroplasty Trauma |
The Patient Specific Distal Femur and its components are for single use only.
The Patient Specific Distal Femur and is components are for cemented use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
| Device Proprietary Name: | Patient Specific Distal Femur |
|---|---|
| Common Name: | Prosthesis, Knee, Femorotibial, Constrained, CementedMetal/Polymer |
| Classification Regulation: | 21 CFR 888.3510 |
| Product Code: | KRO |
| Submitter's Name: | Stanmore Worldwide Implants Ltd. |
| Address: | 210 Centennial AvenueCentennial ParkElstreeWD6 3SJ UNITED KINGDOM |
| Contact Person: | Ed Spearpoint |
| Telephone Number: | +44-20-8238-6500 |
| Fax Number: | +44-20-8953-7443 |
Date Summary Prepared: January 15, 2015
Device Description
The Patient Specific Distal Femur is a patient-specific system that is intended for the replacement of diseased or deficient bone in the distal femur. The Patient Specific Distal Femur and its components are intended for cemented use only. The system is comprised of a range of stems, collars coated with hydroxyappetite (HA) or without coating (stippled or smooth), a range of shafts, femoral components (including axle, bushes and circlip), bumpers and a femoral epiphysis component, (i.e. SMILES TKR).
The materials used in the manufacture of the Patient Specific Distal Femur include titanium alloy (Ti-6Al-4V), cobalt-chromium-molybdenum (Co-Cr-Mo) and ultra-high molecular weight polyethylene (UHMWPE).
The device is for single use only.
Purpose of Submission
This Premarket Notification is being submitted as a modification to the METS® Modular Distal Femur to add patient-specific components and an extra-small option for the knee.
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Intended Use
The Patient Specific 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 resection ●
- Revision of previously failed total joint arthroplasty ●
- . Trauma
The Patient Specific Femur and its components are for single use only.
The Patient Specific Distal Femur and its components are for cemented use only.
Predicate Device(s)
The predicate devices are the METS® Modular Distal Femur, cleared on September 19, 2012 (K121029), the JTS® Extendible Distal Femoral Implant cleared on March 22, 2011(K092138) and the JTS® Extendible Distal Femoral Implant cleared on January 22, 2014 (K133152).
Technological Characteristics
The Patient Specific Distal Femur is a patient-specific implant system that is used to replace diseased or deficient bone in the distal femur. Every configuration includes a knee, femoral shaft, femoral stem and collar.
The Patient Specific Distal Femur is based on the surgeon's prescription and the patient radiological information. The implant is designed and manufactured for each patient.
The Patient Specific Distal Femur is provided sterile by gamma irradiation.
Substantial Equivalence
The Patient Specific Distal Femur has the same intended use and technological characteristics as the METS® Modular Distal Femur (K121029). The difference between the two implant systems is that the current version includes patient-specific components. These new components have been cleared previously by FDA as part of the JTS® Extendible Distal Femoral Implant (K092138 and K133152).
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Performance Data
The Patient Specific Distal Femur has been evaluated through non-clinical performance testing for disassembly of the distal femur and fatigue and wearing testing of the knee. The Patient Specific Distal Femur met all of the acceptance criteria.
The Patient Specific Distal Femur does not alter the fundamental scientific technology of the METS® Modular Distal Femur, alter the indication for use or raise any new questions of safety or effectiveness. Therefore, the Patient Specific Distal Femur is substantially equivalent to its predicate device.
§ 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.