GUARDIAN LIMB SALVAGE SYSTEM

K013035 · Wrightmedicaltechnologyinc · KRO · Dec 7, 2001 · Orthopedic

Device Facts

• Record ID: K013035
• Device Name: GUARDIAN LIMB SALVAGE SYSTEM
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KRO · Orthopedic
• Decision Date: Dec 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GUARDIAN™ Limb Salvage Hip Components: Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/or total femur is required with the following conditions: 1) patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment; 2) surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications; and, 3) matastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors). The GUARDIAN™ Limb Salvage Knee Components: Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and, 5) treatment of fractures that are unmanageable using other techniques. Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions: 1) patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment; 2) surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications; and, 3) matastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors).

Device Story

Modular orthopedic reconstruction system for lower limb salvage; components include femoral neck, mid-sections, stems, distal hinge femur, tibial hinge assembly, axial pin, and tibial sleeves. Used in proximal femur, distal femur, total femur, proximal tibia, and hinged knee reconstruction. System provides structural replacement following radical resection or severe joint arthropathy. Operated by orthopedic surgeons in clinical/surgical settings. Output is a reconstructed skeletal structure restoring limb function and reducing pain. Benefits include salvage of limbs otherwise requiring amputation due to trauma or oncology.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing and design comparison.

Technological Characteristics

Modular orthopedic prosthesis system; components include femoral neck, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, and tibial sleeve. Materials are metal/polymer. Designed for cemented use. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring total hip or knee arthroplasty or radical resection/replacement of proximal/distal/total femur or proximal tibia due to degenerative joint disease (osteoarthritis, rheumatoid arthritis, avascular necrosis), functional deformity, failed prior revision, fracture, severe trauma, or oncology indications (metastatic disease, bone tumors).

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

• Lacey Rotating Hinge Knee
• DCW Modular Distal Femoral System
• S.O.S.™ Proximal Femur

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the word "WRIGHT" in large, bold letters. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." with a line underneath. The address "5677 AIRLINE ROAD ARLINGTON, TN 38002" and phone number "901-867-9971" are printed below the line.

DEC 0 7 2001

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the GUARDIAN™ Limb Salvage System.

| Submitted By: | Wright Medical Technology, Inc. |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 7, 2001 |
| Contact Person: | Ehab M. Esmail<br>Manager, Regulatory Affairs |
| Proprietary Name: | GUARDIAN™ Limb Salvage System |
| Common Name: | Limb Salvage System |
| Classification Name and Reference: | 21 CFR 888.3350 Prosthesis, Hip, Semi-<br>Constrained, Metal/Polymer Cemented- Class II<br>21 CFR 888.3510 Prosthesis, Knee, Femorotibial,<br>Constrained, Cemented, Metal/Polymer – Class II |

Device Product Code and Panel Code:

Orthopedics/87/ JDI, KRO

#### DEVICE INFORMATION

#### A. INTENDED USE

The indications for use for the GUARDIAN™ Limb Salvage System will be substantially equivalent to the indication for use listed under competitive devices previously cleared for market and identical to the indication for use previously submitted under Lacey Rotating Hinge Knee, DCW Modular Distal Femoral System, and. S.O.S.™ Proximal Femur.

Image /page/0/Picture/11 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font, with a line underneath.

Image /page/0/Picture/12 description: The image shows a black and white logo of a globe. The globe is tilted to the right and shows the continents of Asia and Australia. The logo is simple and stylized, with a thick black line representing the outline of the globe. The continents are filled in with black, and the oceans are white.

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K013035
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## GUARDIAN™ Limb Salvage Hip Components:

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2) inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed; and,
- 5) treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal, distal and/or total femur is required with the following conditions:

- 1) patients suffering from severe arthropathy of the hip that does not respond to any conservative therapy or better alternative surgical treatment;
- 2) surgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications; and,
- 3) matastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors).

### The GUARDIAN™ Limb Salvage Knee Components:

Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

- 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- 2) inflammatory degenerative joint disease including rheumatoid arthritis;
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed; and,
- 5) treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:

- 1) patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
- 2) surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications; and,
- 3) matastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors).

Image /page/1/Picture/24 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" above the word "WRIGHT" in a bold, sans-serif font. Below "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.

Image /page/1/Picture/25 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and shows the continents of Asia and Australia. The globe is surrounded by a circular frame, and there is some text at the bottom of the image, but it is unreadable.

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Image /page/2/Picture/1 description: The image shows handwritten text that appears to be a combination of letters and numbers. The text includes 'K013035' and '30F-3', written in a casual, slightly slanted style. The handwriting is clear, but the overall presentation suggests it may be a label or identifier noted quickly.

### B. DEVICE DESCRIPTION

The GUARDIAN™ Limb Salvage System consists of components that are used in the reconstruction of the lower limb. The reconstruction applications are proximal femur, distal femur, total femur, proximal tibia, and hinged knee. The components are femoral neck, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial sleeve spacer, tibial sleeve, male-male mid-section, resurfacing hinge femur, and proximal tibia.

| | RECONSTRUCTION APPLICATIONS | | | | |
|-------------------------|-----------------------------|-----------------|----------------|-------------------|----------------|
| COMPONENTS | PROXIMAL<br>FEMUR | DISTAL<br>FEMUR | TOTAL<br>FEMUR | PROXIMAL<br>TIBIA | HINGED<br>KNEE |
| FEMORAL NECK | ✓ | | ✓ | | |
| MID-SECTION | ✓ | ✓ | ✓ | ✓ | |
| STEM | ✓ | ✓ | ✓ | ✓ | |
| DISTAL HINGE FEMUR | | ✓ | ✓ | | |
| TIBIAL HINGE ASSEMBLY | | ✓ | ✓ | ✓ | ✓ |
| AXIAL PIN | | ✓ | ✓ | ✓ | ✓ |
| TIBIAL SLEEVE SPACER | | ✓ | ✓ | ✓ | ✓ |
| TIBIAL SLEEVE | | ✓ | ✓ | | |
| MALE-MALE MID-SECTION | | | ✓ | | |
| RESURFACING HINGE FEMUR | | | | ✓ | ✓ |
| PROXIMAL TIBIA | | | | ✓ | |

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of GUARDIAN™ Limb Salvage System are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the GUARDIAN™ Limb Salvage System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.

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and the comments of the comment of the starting the first and the first and

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 7 2001

Mr. Ehab M. Esmail Manager, Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002

Re: K013035

Trade/Device Name: GUARDIAN Limb Salvage System Regulation Number: 21 CFR 888.3510; 21 CFR 888.3350 Regulation Name: Er OFF oversion is eetal/polymer constrained cemented prosthesis; Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KRO, JDI Dated: September 7, 2001 Received: September 10, 2001

Dear Mr. Esmail:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared in added is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreaty to ttgansy the Medical Device Amendments, or to conninered pror to May 20, 1978, are oncernance with the provisions of the Federal Food, Drug, devices that have boon roomsomed in avere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may or subject to back as back as 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 I loase of actived that I Dr over device complies with other requirements of the Act that I Dri has made a associations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF art 007), accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quint on control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Ehab M. Esmail

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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page 1 of 2

for Mark n millumor

| (Divisior | |
|-------------------------|-------------|
| Divis. | Restorative |
| and Newblogica services | |
| 510(k) Number | K01305 |
| | 0 |

WRIGHT
MEDICAL TECHNOLOGY, INC.

5677 AIRLINE ROAD
ARLINGTON, TN 38002
901-867-9971

K013035

GUARDIAN™ Limb Salvage System

j Number

### INDICATIONS STATEMENT

### GUARDIAN™ Limb Salvage Hip Components:

OUARDIAN - Limis Burning arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- 2) inflammatory degenerative joint disease such as rheumatoid arthritis;
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed; and,
- 5) treatment of fractures that are unmanageable using other techniques.

Limb salvage system is also indicated for procedures where radical resection and replacement Entho sarvage system is asso total femur is required with the following conditions:

- 1) patients suffering from severe arthropathy of that does not respond to any conservative therapy or better alternative surgical treatment;
- ourgical intervention for severe trauma, revision hip arthroplasties, and/or Oncology indications.
- 3) matastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone tumors)

## The GUARDIAN™ Limb Salvage Knee Components:

Indicated for cemented use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

- 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- 2) inflammatory degenerative joint disease including rheumatoid arthritis;
- 3) correction of functional deformity;
- 4) revision procedures where other treatments or devices have failed; and
- 5) treatment of fractures that are unmanageable using other techniques.

Image /page/5/Picture/25 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a serif font. Below the word "WRIGHT" are the words "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font.

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INDICATIONS STATEMENT

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Limb salvage system is also indicated for procedures where radical resection and replacement of the proximal tibia is required with the following conditions:

- 1) patients suffering from severe arthropathy of the knee that does not respond to any conservative therapy or better alternative surgical treatment;
- 2) surgical intervention for severe trauma, revision knee arthroplasties, and/or Oncology indications.
- matastatic diseases (e.g., osteosarcomas, chondrosarcomas, gaint cell tumors, bone 3) tumors)

# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General Restorative Devices 510(k) Number

Prescription Use
(Per21 CFR 801.109) X

OR

Over-The Counter Use (Optional Format 1-2-96)

Mark M. Millican

Restorative 510(K) V

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Image /page/6/Picture/15 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company."