BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)

K141331 · Biomet, Inc. · JDI · Oct 27, 2014 · Orthopedic

Device Facts

• Record ID: K141331
• Device Name: BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
• Applicant: Biomet, Inc.
• Product Code: JDI · Orthopedic
• Decision Date: Oct 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Proximal and Distal Femoral Reconstruction, Tibial Reconstruction.

Device Story

The Biomet Orthopaedic Salvage System (OSS) is a modular orthopedic implant system for limb salvage reconstruction. It consists of various components including distal/proximal femoral components, proximal tibial sleeves, diaphyseal segments, splined stems, and augments. These components are used by orthopedic surgeons in clinical settings to replace bone and joint structures compromised by tumor, trauma, or failed previous arthroplasty. The system is typically used with bone cement, though certain OsseoTi (titanium alloy) components allow for uncemented bone integration. The device provides structural support and joint function, aiming to restore mobility and alleviate pain in patients with significant bone loss or deformity. The system is modular, allowing surgeons to assemble specific configurations based on the patient's anatomical needs. The output is a reconstructed skeletal segment that restores joint mechanics and limb stability.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence was determined based on non-clinical bench testing, including device fatigue testing, static disassociation testing, tensile properties testing, and material characterization for OsseoTi.

Technological Characteristics

Modular orthopedic implant system. Materials: CoCrMo (for strength) and OsseoTi (porous titanium alloy for bone integration). Features: External taper posts, augment tapers, and suture holes for secondary tissue fixation. Connectivity: None. Energy: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with painful/disabled joints due to avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis; correction of varus, valgus, or posttraumatic deformity; correction/revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement; ligament deficiencies; tumor resections; treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement; revision of previously failed total joint arthroplasty; and trauma. Reduced size components indicated for small adults and adolescents (12-21 years) requiring proximal femoral, distal femoral, total femur, or proximal tibial replacement, or resurfacing of proximal tibia/distal femur.

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

• Biomet Orthopaedic Salvage System (K002757, K052685, K123501)
• Biomet RS (Reduced Size) OSS Additional Components (K051479, K021260)
• Zimmer Segmental System Trabecular Metal Proximal Tibial Component, Trabecular Metal Proximal Femoral Component, and Additional Segment with Male/Female Taper Components (K110940)

Reference Devices

• Biomet Reconstructive Wedges (K122770)
• Regenerex Sleeve Augments (K072336)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 27, 2014

Biomet, Incorporated Tracy Bickel Johnson Regulatory Global Project Manager 56 East Bell Drive Post Office Box 587 Warsaw, Indiana 46581

Re: K141331

Trade/Device Name: Biomet Orthopaedic Salvage System (OSS) Line Extension Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, LPH, KRO Dated: September 24, 2014 Received: September 26, 2014

Dear Ms. Tracy Bickel Johnson,

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K141331

#### Device Name

Biomet Orthopedic Salvage System (OSS) Line Extension

#### Indications for Use (Describe)

#### OSS INDICATIONS

- 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, or traumatic arthritis.
- 2. Correction of varus, valgus, or posttraumatic deformity.
- 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- 4. Ligament deficiencies.
- 5. Tumor resections.
- 6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. *
- 7. Revision of previously failed total joint arthroplasty.

#### 8. Trauma.

These devices are to be used with bone cement unless composed of OsseoTi (titanium allov, not licensed in Canada) or a proximal femur is indicated for use (USA).

Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (USA).

* Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.

#### COMPRESS INDICATIONS

The Compress Segmental Femoral Replacement System is indicated for:

- 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- 2. Tumor resections.
- 3. Revision of previously failed total joint arthroplasty.
- 4. Trauma.

The Compress Segmental Femoral Replacement System components are intended for uncemented use.

When components of the Orthopaedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, the user should refer to the package insert contained with the Compress components for full prescription information.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;"> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/4/Picture/0 description: The image shows the word "BIOMET" in a stylized, sans-serif font. The letters are all capitalized and appear to be outlined or embossed, giving them a three-dimensional effect. A small registered trademark symbol is visible to the upper right of the letter "T". The overall design is clean and modern.

# 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

| Submitter Information | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Biomet Manufacturing, LLC |
| Address | 56 East Bell Drive |
| | PO Box 587 |
| | Warsaw, IN 46581-0857 |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment<br>Registration Number | 1825034 |
| Name of contact person | Tracy Bickel Johnson, RAC |
| Date prepared | 22 August 2014 |
| Name of device | |
| Trade or proprietary<br>name | Biomet Orthopaedic Salvage System (OSS) |
| Common or usual<br>name | Knee/Hip Implants |
| Classification name /<br>Regulation | Prosthesis, hip, semi-constrained, metal/polymer, porous<br>uncemented (21 CFR § 888.3350); |
| | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21<br>CFR § 888.3350); |
| | Prosthesis, Knee, Femorotibial, Constrained, Cemented,<br>Metal/Polymer (21 CFR § 888.3510) |
| Classification panel | Orthopedic |
| Product Code(s) | LPH; JDI; KRO |
| Legally marketed device(s)<br>to which equivalence is | Biomet Orthopaedic Salvage System (K002757, K052685,<br>K123501); |
| claimed | Biomet RS (Reduced Size) OSS Additional Components<br>(K051479/K021260); |
| | Zimmer Segmental System Trabecular Metal Proximal Tibial<br>Component, Trabecular Metal Proximal Femoral Component, and<br>Additional Segment with Male/Female Taper Components<br>(K110940) |
| | Reference Item: Biomet Reconstructive Wedges (K122770)<br>Reference Item: Regenerex Sleeve Augments (K072336) |
| Reason for 510(k)<br>submission | New device |
| Device description | The new devices included in this submission are additional<br>components to Biomet's Orthopaedic Salvage System (OSS) that<br>offer surgeons additional prostheses options to be used in limb<br>salvage reconstruction. The new devices include distal femoral<br>component, proximal femoral component, proximal tibial sleeve,<br>diaphyseal segment, splined stem, diaphyseal augment and<br>metaphyseal augment. |
| Intended use of the device | Proximal and Distal Femoral Reconstruction, Tibial<br>Reconstruction. |
| Indications for use | OSS INDICATIONS<br>1. Painful and disabled joint resulting from avascular necrosis,<br>osteoarthritis, rheumatoid arthritis, or traumatic arthritis.<br>2. Correction of varus, valgus, or posttraumatic deformity.<br>3. Correction or revision of unsuccessful osteotomy, arthrodesis,<br>or previous joint replacement.<br>4. Ligament deficiencies.<br>5. Tumor resections.<br>6. Treatment of non-unions, femoral neck fracture, and<br>trochanteric fractures of the proximal femur with head<br>involvement, unmanageable using other techniques. *<br>7. Revision of previously failed total joint arthroplasty.<br>8. Trauma.<br><br>These devices are to be used with bone cement unless composed<br>of OsseoTi (titanium alloy, not licensed in Canada) or a proximal<br>femur is indicated for use (USA).<br><br>Biomet OSS Reduced size (RS) components offers a variety of<br>component options for treatment in small adults and adolescents<br>(12-21 years) that require proximal femoral, distal femoral, total<br>femur, or proximal tibial replacement as well as, resurfacing<br>components for the proximal tibia and distal femur (USA).<br><br>* Not applicable to Regenerex Ultra Porous Construct titanium<br>knee augment usage (not licensed in Canada), or any other knee<br>component.<br><br>COMPRESS INDICATIONS<br>The Compress Segmental Femoral Replacement System is<br>indicated for:<br>1. Correction of revision of unsuccessful osteotomy,<br>arthrodesis, or previous joint replacement.<br>2. Tumor resections.<br>3. Revision of previously failed total joint arthroplasty.<br>4. Trauma. |
| Summary of the Technologies | The Compress Segmental Femoral Replacement System components are intended for uncemented use.<br><br>When components of the Orthopaedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, the user should refer to the package insert contained with the Compress components for full prescription information. |

Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587 Toll Free: 800.348.9500
Office: 574.267.6639
Main Fax: [phone] www.biomet.com

Shipping Address:
56 East Bell Drive
Warsaw, IN 46582

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The new devices are modifications to the predicate devices (K002757, K052685,

K051479/K021260 and K110940) in the following ways:

- Distal femoral components (with optional augments) are modified with aesthetic profile update and an external taper post feature;
- Splined stems are modified with material change to CoCrMo;
- . Diaphyseal segments are modified with an external augment taper feature and material change to CoCrMo;
- . Proximal tibial sleeves are modified with material change to OsseoTi® and additional suture holes for optional tissue attachment method utilizing optional spiked washers and bolts;
- . Metaphyseal augments are modified with augment taper feature and material change to OsseoTi":
- . Diaphyseal augments are modified with material change to OsseoTi™ and geometry updates to be compatible with OSS devices

The external taper post feature and external augment taper feature are incorporated so that new devices are compatible with other OSS components (K002757, K052685, and K051479). Material change to CoCrMo for its material strength, and to OsseoTi™ to enhance the potential for bone integration. The OsseoTi™ material and process for the devices included in this submission is identical as which cleared in Biomet Reconstructive Wedges K122770. Cleaning of OsseoTi is identical to Regenerex materials which were previously cleared in K072336.

New proximal sleeves are updated with additional suture holes for optional use with spiked washers and bolts as optional secondary tissue fixation method. Primary tissue fixation method remains the same as predicate device.

# PERFORMANCE DATA

# SUMMARY OF NON-CLINICAL TESTS

## Performance Test Summary-New Device

Device Fatique Testing Device Static Disassociation Testing Tensile Properties Testing Material Characterization for OsseoTi Cleaning

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## SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Clinical Performance Data/Information: N/A

## CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

No clinical testing was necessary for a determination of substantial equivalence.

The results of device fatigue testing, static disassociation testing and material characterization studies indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.