(166 days)
No
The document describes a standard modular orthopedic implant system for total femur replacement and does not mention any AI or ML components or functionalities.
Yes
The device is described as a replacement for diseased or deficient bone in the femur, intended for conditions like avascular necrosis, osteoarthritis, and trauma, which aligns with the definition of a therapeutic device that treats or alleviates a medical condition.
No
The device is a modular system intended for the replacement of the total femoral bone, not for diagnosing medical conditions. It is an implant used in surgical procedures.
No
The device description clearly outlines physical components made of titanium, cobalt-chromium-molybdenum, and ultra high molecular weight polyethylene, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "replacement of the total femoral bone" and is used in surgical procedures for limb salvage, joint replacement, and trauma. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials and components of a physical implant designed to replace bone and joint structures. It does not describe reagents, instruments, or software used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
The device is a surgical implant used to treat musculoskeletal conditions by replacing damaged or diseased bone and joint structures.
N/A
Intended Use / Indications for Use
The METS® Modular Total Femur is intended for the replacement of the total femoral bone.
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
Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
METS® Modular Total Femur tibial and acetabular components are for cemented use only.
METS® Modular Total Femur and their components are for single use only.
Product codes
JDI, KRO
Device Description
The single use METS® Modular Total Femur is a standard modular system that is intended for the replacement of diseased or deficient bone in the femur. The system is intended for cemented use only and comprises titanium (Ti) components including a trochanter section, shaft. The trochanter trunnion is made to interchange with Stanmore Implants Worldwide Limited's, 28mm and 32mm Ø Cobalt Chrome femoral heads. The METS® Modular Total Femur is offered with an optional set of trochanters which are only to be used for hard tissue attachment using a plate and two screws, or Ti or cobalt chromium (CoCr) wire.
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, Hip joint, Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
Clinical Performance Conclusions
Clinical evaluation was carried out based upon published papers and post market surveillance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K092138, K002757, K023087, K963313, K021489
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K121055 (1/2)
SECTION 5: 510(k) SUMMARY
SECTION 5:
510(k) SUMMARY
Preparation Date: September 10, 2012
Trade Name: METS® MODULAR TOTAL FEMUR
Common Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Classification Name: Hip joint metal/polymer semi-constrained cemented prosthesis
(21 CFR 888.3350, Product Code JDI) Knee joint femorotibial
metal/polymer constrained cemented prosthesis (21 CFR
888.3510, Product Code KRO)
Applicant/Sponsor: Stanmore Implants Worldwide Ltd
210 Centennial Avenue
Centennial Park
Elstree
WD6 3SJ
Phone: +44 (0) 20 8238 6503
Facsimile: +44 (0) 20 8954 0351
Contact Person: Nancy MacDonald
Manager of Regulatory Affairs
Health Policy Associates Inc.
Email: nmacdonald@healthpolicyassociates.com
Tel: (781) 329-2993
Fax: (781) 329-2958
Equivalent to: JTS Extendible Implant, Stanmore Implants (K092138)
Orthopaedic Salvage System (OSS); Biomet (K002757) Global
Modular Replacement System (GMRS); Howmedica (Stryker)
(K023087); Exactec Inc All Poly Acetabular Cup (K963313) and
the Repiphysis Limb Salvage System Wright Medical (K021489).
Device Description: The single use METS® Modular Total Femur is a standard
modular system that is intended for the replacement of diseased or
deficient bone in the femur. The system is intended for cemented
use only and comprises titanium (Ti) components including a
trochanter section, shaft. The trochanter trunnion is made to
interchange with Stanmore Implants Worldwide Limited's, 28mm
and 32mm Ø Cobalt Chrome femoral heads. The METS®
Modular Total Femur is offered with an optional set of trochanters
which are only to be used for hard tissue attachment using a plate
and two screws, or Ti or cobalt chromium (CoCr) wire.
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).
SEP 17 2012
1
| | The materials used in the manufacture of the systems include
titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra
high molecular weight polyethylene (UHMWPE). |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The METS® Modular Total Femur is intended for the replacement
of the total femoral bone. |
| Indications for Use: | 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
Treatment of non-unions, femoral neck and trochanteric fracture of
the proximal femur with head involvement, unmanageable using
other techniques
METS® Modular Total Femur tibial and acetabular components are
for cemented use only.
METS® Modular Total Femur and their components are for single
use only. |
| Performance Data:
(non-clinical and
clinical) | 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. |
| | Clinical Performance Conclusions
Clinical evaluation was carried out based upon published papers
and post market surveillance. |
| Substantial
Equivalence: | The METS® Modular Total Femur is equivalent to the following
predicate devices: the JTS Extendible Implant (K092138); the
Biomet OSS (K002757); the Howmedica (Stryker) GMRS
(K023087); the Exactec All Poly Acetabular Cup (K963313) and
the Repiphysis Limb Salvage System (K021489). 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. |
2
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stanmore Implants Worldwide, Limited % Health Policy Associates, Incorporated Ms. Nancy C. McDonald Manager, Regulatory Affairs 690 Canton Street, Suite 302 Westwood, Massachusetts 02090
SEP 17 2012
Re: K121055
Trade/Device Name: METS® MODULAR TOTAL FEMUR Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/composite semi-constrained cemented prothesis Regulatory Class: Class II Product Code: JDI, KRO Dated: August 17, 2012 Received: August 17, 2012
Dear Ms. McDonald:
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Ms. Nancy C. McDonald
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 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 McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
METS® MODULAR TOTAL FEMUR.
Device Name:
Indications for Use: The METS® Modular Total Femur is intended for the replacement of the total femoral bone.
121055
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
Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
All of the METS® Modular Total Femur tibial and acetabular components are for cemented use only
All of the METS® Modular Total Femur and their components are for single use only
Prescription Use X (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
BAPinds for
Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121055