METS MODULAR PROXIMAL FEMUR

K121056 · Stanmore Implants Worldwide , Ltd. · JDI · Sep 20, 2012 · Orthopedic

Device Facts

• Record ID: K121056
• Device Name: METS MODULAR PROXIMAL FEMUR
• Applicant: Stanmore Implants Worldwide , Ltd.
• Product Code: JDI · Orthopedic
• Decision Date: Sep 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The METS® Modular Proximal Femur is intended for the replacement of diseased or deficient bone in the proximal 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 Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques Revision of previously failed total joint arthroplasty Trauma The METS® Modular Proximal Femur and its components are for single use only The METS® Modular Proximal Femur and its components are for cemented use only

Device Story

METS® Modular Proximal Femur is a modular orthopedic implant system for proximal femur replacement. Components include titanium trochanter section, shaft (with/without extension), stem, and collar; compatible with 28mm/32mm Cobalt Chrome femoral heads. Designed for cemented use only in limb salvage or reconstructive procedures. Optional trochanters allow hard tissue attachment via plates/screws or wires. Used by orthopedic surgeons in clinical/surgical settings to replace diseased/deficient bone, correct deformities, or revise failed arthroplasties. Provides structural support to restore joint function and alleviate pain.

Clinical Evidence

Clinical evaluation based on published literature and post-market surveillance. No prospective clinical trial data provided for this specific submission.

Technological Characteristics

Modular proximal femoral prosthesis. Materials: Titanium (Ti) and Cobalt-Chromium-Molybdenum (CoCrMo). Components: trochanter section, shaft, stem, collar. Surface options: hydroxyapatite (HA) coated or uncoated, stippled or smooth. Cemented fixation only. Single-use. Mechanical assembly via taper connections.

Indications for Use

Indicated for patients requiring proximal femur replacement due to disease or deficiency, including limb salvage, avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis, deformity correction (varus/valgus/post-traumatic), revision of failed osteotomy/arthrodesis/joint replacement, ligament deficiencies, tumor resections, non-unions, and femoral neck/trochanteric fractures with head involvement.

Regulatory Classification

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).

Predicate Devices

• JTS Extendible Implant (K092138)
• Orthopaedic Salvage System (OSS) (K002757)
• Modular Replacement System (GMRS) (K023087)
• Exactec Inc All Poly Acetabular Cup (K963313)

Submission Summary (Full Text)

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121056

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SEP 2 0 2012

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# SECTION 5: 510(k) SUMMARY

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| Preparation Date | September 7, 2012 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | METS® MODULAR PROXIMAL FEMUR |
| Classification Name: | Hip joint metal/polymer semi-constrained cemented prosthesis<br>(21 CFR 888.3350, Product Code JDI) |
| 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: | JTS Extendible Implant, Stanmore Implants (K092138)<br>Orthopaedic Salvage System (OSS) Biomet (K002757) Global<br>Modular Replacement System (GMRS) Howmedica (Stryker)<br>(K023087), Exactec Inc All Poly Acetabular Cup (K963313) |
| Device Description: | The single use METS® Modular Proximal Femur is a standard<br>modular system that is intended for the replacement of diseased or<br>deficient bone in the proximal femur. The system is intended for<br>cemented use only and comprises titanium (Ti) components<br>including a trochanter section, shaft with or without an integral<br>extension piece, stem and collar that is available hydroxyapatite<br>(HA) coated or uncoated, stippled or smooth. The trochanter<br>trunnion is made to interchange with Stanmore Implants<br>Worldwide Limited's 28mm and 32mm Ø Cobalt Chrome<br>femoral heads. The METS® Modular Proximal Femur is offered<br>with an optional set of trochanters which are only to be used<br>forhard tissue attachment using a plate and two screws, or Ti or<br>cobalt chromium (CoCr) wire.<br>The materials used in the manufacture of the systems include titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) |

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121056.

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Intended Use:

Indications for Use

The METS® Modular Proximal Femur is intended for the replacement of diseased or deficient bone in the proximal 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 proximal femur with head involvement, unmanageable using other techniques

Revision of previously failed total joint arthroplasty Trauma

The METS® Modular Proximal Femur and its components are for single use only

The METS® Modular Proximal Femur and its components are for cemented use only

#### 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: disassembly force testing for the taper connections.

#### Clinical Performance Conclusions

Clinical evaluation was carried out based upon published papers and post market surveillance.

The METS® Modular Proximal Femur is equivalent to the JTS Extendible Implant, (K092138), OSS (K002757) and the (GMRS) Howmedica (Stryker) (K023087) and All Poly Acetabular Cup (K963313), 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.

Performance Data (non-clinical and clinical)

Substantial Equivalence:

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is a stylized image of three lines that appear to be flowing or moving.

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. MacDonald Manager, Regulatory Affairs 690 Canton Street, Suite 302 Westwood, Massachusetts 02090

SEP 20 2012

Re: K121056

Trade/Device Name: METS®MODULAR PROMIXAL FEMUR Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI Dated: September 10, 2012 Received: September 11, 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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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# Page 2 - Ms. Nancy C. MacDonald

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,

cerely yours,

Ron Noller

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): | K121056 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

## METS® MODULAR PROXIMAL FEMUR

Indications for Use:

Intended for the replacement of diseased or deficient bone in the proximal 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

Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques

Revision of previously failed total joint arthroplasty

Trauma

The METS® Modular Proximal Femur and its components are for single use only

The METS® Modular Proximal Femur and its components are for cemented use only

Prescription Use X AND/ OR

(Per 21 CFR 801 Subpart D)

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)

Asto

(Division Sign-Cil) Division of Surveal. Orthopedic, and Restorative Devices

k121056 510(k) Number _