K Number
K142814
Device Name
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
Date Cleared
2015-06-25

(269 days)

Product Code
Regulation Number
888.3350
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OSS INDICATIONS 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, 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 alloy, 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, distal 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. EXPANDABLE INDICATIONS The Biomet Side Access Distal Femoral Expandable offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement. The devices are single use implants intended for implantation with bone cement or with Biomet Compress.
Device Description
The new devices included in this submission are additional components to Biomet's Orthopaedic Salvage System (OSS) that offer surgeons additional prostheses options to be used in limb salvage reconstruction. The new devices include proximal femoral components and tibial components.
More Information

No
The document describes orthopedic implants and their intended use, device description, and performance testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on mechanical properties and range of motion, not algorithmic performance.

Yes
The device is an orthopedic implant (Orthopaedic Salvage System) designed to correct painful and disabled joints, deformities, and trauma, which aligns with the definition of a therapeutic device.

No

This device is a surgical implant system used for limb salvage reconstruction, not for diagnosing medical conditions. It is intended for treatment, not diagnosis.

No

The device description clearly states the new devices are "additional components to Biomet's Orthopaedic Salvage System (OSS)" and includes "proximal femoral components and tibial components." These are physical implants, not software. The performance studies also focus on material and mechanical properties (fatigue testing, ROM analysis, material characterization), further indicating a hardware device.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
  • Device Description: The description clearly states the devices are "additional components to Biomet's Orthopaedic Salvage System (OSS) that offer surgeons additional prostheses options to be used in limb salvage reconstruction." These are implants intended for surgical use within the body.
  • Intended Use/Indications for Use: The indications all relate to surgical procedures and conditions affecting bones and joints, requiring the implantation of prosthetic components.
  • Lack of IVD Characteristics: There is no mention of analyzing samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.

Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

Indications for Use (Describe)

OSS INDICATIONS

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

These devices are to be used with bone cement unless composed of OsseoTi (titanium alloy, 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:

  • I. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
    1. Tumor resections.
    1. Revision of previously failed total joint arthroplasty.
    1. 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.

EXPANDABLE INDICATIONS

The Biomet Side Access Distal Femoral Expandable offers a treatment requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; theumatoid arthritis; correction of deformity; and correction of unsuccessful osteotomy, arthrodesis or previous joint replacement.

The devices are single use implants intended for implantation with bone cement or with Biomet Compress.

Intended use of the device

Proximal Femur, Total Femoral Reconstruction, and Proximal Tibia Reconstruction.

Product codes (comma separated list FDA assigned to the subject device)

JDI, LPH, KRO

Device Description

The new devices included in this submission are additional components to Biomet's Orthopaedic Salvage System (OSS) that offer surgeons additional prostheses options to be used in limb salvage reconstruction. The new devices include proximal femoral components and tibial components.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Proximal Femur, Total Femoral, Proximal Tibia, distal femoral

Indicated Patient Age Range

Small adults and adolescents (12-21 years), patients who have not yet achieved full skeletal maturity (open epiphysis)

Intended User / Care Setting

Surgeons / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

SUMMARY OF NON-CLINICAL TESTS

Performance Test Summary-New Device
Device Fatigue Testing, proximal femoral and hybrid tibia
Range-of-Motion (ROM) Analysis Material Characterization for OsseoTi™

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Biomet RS (Reduced Size) OSS Additional Components Primary predicate for proximal tibia (K021260), Biomet Vanguard Removable Molded Poly Tibia (K102580), Stryker/Howmedica GMRS All Poly Tibia (K031480/K992346), Biomet Segmental Distal Femoral Component and Proximal Femoral Bodies - Primary predicate for proximal femur (K080330), Biomet G7 OsseoTi Acetabular Shell (K140669), Biomet OSS Les Proximal Component (K021380), Biomet Orthopaedic Salvage System-OSS (K141331)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Biomet Reconstructive Wedges (K122770), Regenerex Knee Augments (K072336), Orthopaedic Salvage System- OSS (K002757)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.

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

June 25, 2015

Biomet Manufacturing LLC Ms. Tracv Bickel Johnson Global Regulatory Project Manager 56 East Bell Drive Warsaw, Indiana 46581

Re: K142814

Trade/Device Name: Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial 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: May 26, 2015 Received: May 28, 2015

Dear Ms. 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 (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

1

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely vours.

Mark N. Melkerson -S

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

Enclosure

2

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142814

Device Name

Biomet Orthopaedic Salvage System (OSS™)- Proximal Femoral & Hybrid Tibial

Indications for Use (Describe)

OSS INDICATIONS

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

These devices are to be used with bone cement unless composed of OsseoTi (titanium alloy, 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:

  • I. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
    1. Tumor resections.
    1. Revision of previously failed total joint arthroplasty.
    1. 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.

EXPANDABLE INDICATIONS

The Biomet Side Access Distal Femoral Expandable offers a treatment requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; theumatoid arthritis; correction of deformity; and correction of unsuccessful osteotomy, arthrodesis or previous joint replacement.

The devices are single use implants intended for implantation with bone cement or with Biomet Compress.

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Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

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

Submitter Information
NameBiomet Manufacturing, LLC
Address56 East Bell Drive
PO Box 587
Warsaw, IN 46581-0857
Phone number(574) 372-1761
Fax number(574) 372-1683
Establishment Registration
Number1825034
Name of contact personTracy Bickel Johnson, RAC
Date prepared25 June 2015
Name of deviceBiomet Orthopaedic Salvage System (OSS)
Trade or proprietary
nameBiomet Orthopaedic Salvage System (OSS)
Common or usual
nameKnee/Hip Implants
Classification name /
RegulationProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
(21 CFR § 888.3350),
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous
Uncemented (21 § CFR 888.3358),
Prosthesis, Knee, Femorotibial, Constrained, Cemented,
Metal/Polymer (21 CFR § 888.3510)
Classification panelOrthopedic
Product Code(s)JDI, LPH, KRO
Legally marketed device(s)
to which equivalence is
claimedBiomet RS (Reduced Size) OSS Additional Components Primary
predicate for proximal tibia (K021260),
Biomet Vanguard Removable Molded Poly Tibia (K102580),
Stryker/Howmedica GMRS All Poly Tibia (K031480/K992346),
Biomet Segmental Distal Femoral Component and Proximal
Femoral Bodies - Primary predicate for proximal femur
(K080330),
Biomet G7 OsseoTi Acetabular Shell (K140669),
Biomet OSS Les Proximal Component (K021380), and
Biomet Orthopaedic Salvage System-OSS (K141331)
Reference Items: Biomet Reconstructive Wedges (K122770),
Regenerex Knee Augments (K072336), and Orthopaedic Salvage
System- OSS (K002757)
Reason for 510(k)
submissionNew device
Device descriptionThe new devices included in this submission are additional
components to Biomet's Orthopaedic Salvage System (OSS)
that offer surgeons additional prostheses options to be used in
limb salvage reconstruction. The new devices include proximal
femoral components and tibial components.
Intended use of the deviceProximal Femur, Total Femoral Reconstruction, and Proximal
Tibia Reconstruction.
Indications for useOSS INDICATIONS
  1. Painful and disabled joint resulting from avascular necrosis,
    osteoarthritis, rheumatoid arthritis, 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 alloy, 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, distal
    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. | |
    | EXPANDABLE INDICATIONS
    The Biomet Side Access Distal Femoral Expandable offers a
    treatment option for patients requiring distal femoral
    replacement who have not yet achieved full skeletal maturity
    (open epiphysis) or patients who require surgery who have
    significant residual leg length discrepancy. Indication for use of
    this device is most commonly tumor resection but could also
    involve osteoarthritis; rheumatoid arthritis; correction of
    deformity; and correction or revision of unsuccessful
    osteotomy, arthrodesis or previous joint replacement. | |
    | The devices are single use implants intended for implantation
    with bone cement or with Biomet Compress. | |

Mailing Address:
P.O. Box 587
Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639
Main Fax: 574.267.8137 www.biomet.com

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Image /page/6/Picture/0 description: The image shows the word "BIOMET" in a stylized, sans-serif font. The letters are bold and appear to be outlined, giving them a three-dimensional effect. A registered trademark symbol is present to the upper right of the letter "T".

Summary of the Technologies

The new devices are modifications to the predicate devices (K021260, K102580, K031480/K992346, K080330, K140669, and K021380) in the following ways:

  • Hybrid Poly tibial components have metallic baseplate with polyethylene stem
  • Proximal femoral body is incorporated with an external male taper
  • Optional OsseoTi™ proximal femoral augment
  • . Various spiked washer and bolt combinations

The Hybrid Poly tibial components utilize a polyethylene stem that is mechanically locked to the metallic baseplate. A separate polyethylene bearing component (previously cleared) will be utilized as part of the constrained knee system. These components will primarily be used in adolescent patients that have an open epiphysis.

The external taper post feature and external augment taper feature are incorporated so that new devices are compatible with other OSS components. An optional OsseoTi" Proximal femoral augment can attach to the subject proximal femoral body for soft tissue attachment. The OsseoTi" material and process for the devices included in this submission is identical to those components cleared in Biomet G7 OsseoTi Acetabular Shell (K140669) and Biomet Orthopaedic Salvage System-OSS (K141331).

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS

Performance Test Summary-New Device

Device Fatigue Testing, proximal femoral and hybrid tibia

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Image /page/7/Picture/0 description: The image shows the word "BIOMET" in a stylized, sans-serif font. The letters are thick and blocky, with a slightly rounded appearance. A registered trademark symbol is located in the upper right corner of the image. The color of the text is gray, and the background is white.

Range-of-Motion (ROM) Analysis Material Characterization for OsseoTi™

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 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.