METS MODULAR DISTAL FEMUR

K121029 · Stanmore Implants Worldwide , Ltd. · KRO · Sep 19, 2012 · Orthopedic

Device Facts

• Record ID: K121029
• Device Name: METS MODULAR DISTAL FEMUR
• Applicant: Stanmore Implants Worldwide , Ltd.
• Product Code: KRO · Orthopedic
• Decision Date: Sep 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

METS Modular Distal Femur is a modular orthopedic prosthesis for distal femur replacement. System includes stems, collars (HA-coated or uncoated), shafts, femoral component (axle, bushes, circlip), bumper, and SMILES knee (fixed or rotating). Materials: titanium (Ti), cobalt-chromium-molybdenum (CoCrMo), and ultra-high molecular weight polyethylene (UHMWPE). Device is intended for surgical implantation by orthopedic surgeons in clinical settings to restore joint function in patients with bone deficiency or disease. It functions as a constrained, cemented prosthesis. Clinical benefit includes restoration of mobility and structural integrity following resection or trauma. Device is single-use.

Clinical Evidence

Clinical evaluation based on published literature and post-market surveillance. No new clinical trials were conducted for this submission. Bench testing included knee fatigue and wear testing, and disassembly force testing for taper connections per ASTM F1800-07.

Technological Characteristics

Modular distal femur prosthesis. Materials: Titanium (Ti), CoCrMo, and UHMWPE. Constrained, cemented design. Components include stems, shafts, femoral component, and SMILES knee. Testing performed per ASTM F1800-07. Sterilization method not specified.

Indications for Use

Indicated for patients requiring distal femur bone replacement due to limb salvage (radical resection), avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis, varus/valgus/post-traumatic deformity, failed osteotomy/arthrodesis/joint replacement, ligament deficiencies, tumor resections, or trauma. For single-use, cemented application only.

Regulatory Classification

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).

Predicate Devices

• JTS Extendible Implant, Stanmore Implants (K092138)
• Orthopaedic Salvage System (OSS) Biomet (K002757)
• Modular Replacement System (GMRS) Howmedica (Stryker) (K023087)
• Repiphysis Limb Salvage System Wright Medical (K021489)

Submission Summary (Full Text)

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# 长121029

## SEP 1 9 2012

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#### 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 Ltd<br>210 Centennial Avenue<br>Centennial Park<br>Elstree<br>WD6 3SJ<br>Phone: + 44 (0) 20 8238 6503<br>Facsimile: [phone] |
| Contact Person: | Nancy MacDonald<br>Manager of Regulatory Affairs<br>Health Policy Associates Inc.<br>Email: [e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Equivalent to: | JTŞ Extendible Implant, Stanmore Implants (K092138)<br>Orthopaedic Salvage System (OSS) Biomet (K002757) Global<br>Modular Replacement System (GMRS) Howmedica (Stryker)<br>(K023087) and the Repiphysis Limb Salvage System Wright<br>Medical (K021489) |
| Device Description: | The single use METS® Modular Distal Femur is a standard<br>modular system that is intended for the replacement of diseased or<br>deficient bone in the distal femur. The stems of the system are<br>intended for cemented use only. The system comprises a range of<br>stems, collars hydroxyapatite (HA) coated or without, (stippled or<br>smooth), a range of shafts, femoral component (including axle,<br>bushes and circlip), bumper and the SMILES knee (available in 3<br>types of arrangements, and in a rotating or fixed configuration).<br><br>The materials used in the manufacture of the systems include<br>titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra<br>high 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)