METS MODULAR TOTAL FEMUR

• K Number: K121055
• Device Name: METS MODULAR TOTAL FEMUR
• Manufacturer: STANMORE IMPLANTS WORLDWIDE LTD.
• Date Cleared: 2012-09-19 ( 166 days)
• Product Code: JDI , KRO
• Regulation Number: 888.3350
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K092138 , K002757 , K023087 , K963313 , K021489
• Predicate For: N/A

Intended 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
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

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).

AI/ML Overview

The provided text describes a medical device, the METS® MODULAR TOTAL FEMUR, and its regulatory clearance process (510(k) summary). However, it does not contain information related to software performance, AI algorithms, or detailed acceptance criteria for a study proving such performance.

The "Performance Data" section specifically states:

• 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." This refers to mechanical and material performance of the physical implant, not a software or AI component.
• Clinical Performance Conclusions: "Clinical evaluation was carried out based upon published papers and post market surveillance." This indicates a review of existing literature and real-world data, not a specific clinical study with defined acceptance criteria for a device's performance that would involve expert review or ground truth establishment in the way your request describes.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance: This document does not define numerical acceptance criteria for "device performance" in the context of an algorithm or AI.
2. Sample size used for the test set and data provenance: No such test set is described for performance evaluation in the context of an algorithm.
3. Number of experts used to establish ground truth and their qualifications: Not applicable to the type of performance data presented.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or reported for this device's performance as described.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical implant.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
9. How ground truth for the training set was established: Not applicable.

The document focuses on the mechanical safety and effectiveness of a femoral implant and its substantial equivalence to previously cleared predicate devices, based on physical testing and literature review. It is not an AI/software device and thus does not include the type of performance study details you are asking for.

Summary

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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: [phone]
Facsimile: [phone]

Contact Person: Nancy MacDonald
Manager of Regulatory Affairs
Health Policy Associates Inc.
Email: [e-mail]
Tel: [phone]
Fax: [phone]

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

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	The materials used in the manufacture of the systems includetitanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultrahigh molecular weight polyethylene (UHMWPE).
Intended Use:	The METS® Modular Total Femur is intended for the replacementof the total femoral bone.
Indications for Use:	Limb salvage procedures where radical resection and replacementof the bone is requiredPainful and disabled joint resulting from avascular necrosisosteoarthritis, rheumatoid arthritis or traumatic arthritisCorrection of varus, valgus or post traumatic deformityCorrection of revision of unsuccessful osteotomy, arthrodesis, orprevious joint replacementLigament deficienciesTumor resectionsRevision of previously failed total joint arthroplastyTraumaTreatment of non-unions, femoral neck and trochanteric fracture ofthe proximal femur with head involvement, unmanageable usingother techniquesMETS® Modular Total Femur tibial and acetabular components arefor cemented use only.METS® Modular Total Femur and their components are for singleuse only.
Performance Data:(non-clinical andclinical)	Non Clinical TestingThe results of the non-clinical performance testing demonstratethat the device is safe and effective and substantially equivalentto the predicate devices. The Performance testing included: kneefatigue and wear test, disassembly force testing for the taperconnections, ASTM F1800-07.
	Clinical Performance ConclusionsClinical evaluation was carried out based upon published papersand post market surveillance.
SubstantialEquivalence:	The METS® Modular Total Femur is equivalent to the followingpredicate devices: the JTS Extendible Implant (K092138); theBiomet OSS (K002757); the Howmedica (Stryker) GMRS(K023087); the Exactec All Poly Acetabular Cup (K963313) andthe Repiphysis Limb Salvage System (K021489). Thedetermination of substantial equivalence is based on thesimilarity of the intended use, indications for use, design /technological characteristics, materials of composition, methodof sterilization, performance data and clinical evaluation.

2

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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

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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 [phone] or [phone] 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

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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

Regulation Number and Section

§ 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.