(269 days)
OSS INDICATIONS
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or 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, unmanageable using other techniques. *
- Revision of previously failed total joint arthroplasty.
- 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:
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
- 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.
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.
The provided text describes a 510(k) premarket notification for the Biomet Orthopaedic Salvage System (OSS™) and related components. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, primarily through non-clinical testing. As such, it does not contain the kind of detailed information about acceptance criteria for a device's performance, human reader studies, or training/test set specifics that would typically be found in an AI/ML device submission.
Therefore, many of the requested fields cannot be filled from this document. However, based on the information available, here's what can be provided and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Summary of Results) |
|---|---|
| Device Fatigue Testing (proximal femoral and hybrid tibia) | Results indicated the devices performed within the intended use and met performance requirements. |
| Range-of-Motion (ROM) Analysis | Results indicated the devices performed within the intended use and met performance requirements. |
| Material Characterization for OsseoTi™ | The OsseoTi™ material and process for the new devices are identical to components cleared in predicate devices (K140669 and K141331) and performed within the intended use, not raising new safety or efficacy issues. |
| Overall Safety and Effectiveness (compared to predicate) | The new devices did not raise any new safety and efficacy issues compared to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is non-clinical (mechanical and material characterization), not involving human patient data or a "test set" in the context of AI/ML evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided for this non-clinical submission. Ground truth determination by experts is not relevant to the mechanical and material testing described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for this non-clinical submission. Adjudication methods are typically used for establishing ground truth in clinical evaluations, which were not performed here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. This submission is for a physical orthopedic implant, not an AI/ML diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This submission is for a physical orthopedic implant, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. The "ground truth" for the non-clinical tests would be established engineering standards, material properties specifications, and mechanical performance requirements, rather than clinical ground truth types listed.
8. The sample size for the training set
This information is not applicable/provided. There is no AI/ML training set involved in this submission.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no AI/ML training set involved in this submission.
Summary of the Study:
The studies conducted for the Biomet Orthopaedic Salvage System (OSS™) - Proximal Femoral & Hybrid Tibial were non-clinical performance tests aimed at demonstrating the device's substantial equivalence to existing predicate devices.
The studies included:
- Device Fatigue Testing: Performed on proximal femoral and hybrid tibial components.
- Range-of-Motion (ROM) Analysis: Likely assessed the mechanical range of motion of the components.
- Material Characterization: Specifically for the OsseoTi™ material, confirming it is identical to previously cleared materials.
The conclusion of these non-clinical tests was that "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." No clinical testing was deemed necessary for this determination.
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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
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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
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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
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, or traumatic arthritis.
-
- Correction of varus, valgus, or posttraumatic deformity.
-
- Correction or 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, unmanageable using other techniques. *
-
- Revision of previously failed total joint arthroplasty.
- 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.
-
- Tumor resections.
-
- Revision of previously failed total joint arthroplasty.
-
- 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)
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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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Image /page/4/Picture/0 description: The image shows the logo for Biomet, a medical device company. The logo is in a sans-serif font and is all caps. The letters are bold and have a slightly rounded appearance. The registered trademark symbol is located in the upper right corner of the logo. The logo is in grayscale.
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 DrivePO Box 587Warsaw, IN 46581-0857 |
| Phone number | (574) 372-1761 |
| Fax number | (574) 372-1683 |
| Establishment RegistrationNumber | 1825034 |
| Name of contact person | Tracy Bickel Johnson, RAC |
| Date prepared | 25 June 2015 |
| Name of device | Biomet Orthopaedic Salvage System (OSS) |
| Trade or proprietaryname | Biomet Orthopaedic Salvage System (OSS) |
| Common or usualname | Knee/Hip Implants |
| Classification name /Regulation | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented(21 CFR § 888.3350),Prosthesis, Hip, Semi-Constrained, Metal/Polymer, PorousUncemented (21 § CFR 888.3358),Prosthesis, Knee, Femorotibial, Constrained, Cemented,Metal/Polymer (21 CFR § 888.3510) |
| Classification panel | Orthopedic |
| Product Code(s) | JDI, LPH, KRO |
| Legally marketed device(s)to which equivalence isclaimed | Biomet RS (Reduced Size) OSS Additional Components Primarypredicate 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 ProximalFemoral Bodies - Primary predicate for proximal femur(K080330),Biomet G7 OsseoTi Acetabular Shell (K140669),Biomet OSS Les Proximal Component (K021380), andBiomet Orthopaedic Salvage System-OSS (K141331)Reference Items: Biomet Reconstructive Wedges (K122770),Regenerex Knee Augments (K072336), and Orthopaedic SalvageSystem- OSS (K002757) |
| Reason for 510(k)submission | New device |
| Device description | The new devices included in this submission are additionalcomponents to Biomet's Orthopaedic Salvage System (OSS)that offer surgeons additional prostheses options to be used inlimb salvage reconstruction. The new devices include proximalfemoral components and tibial components. |
| Intended use of the device | Proximal Femur, Total Femoral Reconstruction, and ProximalTibia Reconstruction. |
| Indications for use | OSS INDICATIONS1. 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, andtrochanteric fractures of the proximal femur with headinvolvement, unmanageable using other techniques. 7. Revision of previously failed total joint arthroplasty.8. Trauma.These devices are to be used with bone cement unlesscomposed 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 ofcomponent options for treatment in small adults andadolescents (12-21 years) that require proximal femoral, distalfemoral, 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 Constructtitanium knee augment usage (not licensed in Canada), or anyother knee component.COMPRESS INDICATIONSThe Compress Segmental Femoral Replacement System isindicated 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 Systemcomponents are intended for uncemented use. | |
| When components of the Orthopaedic Salvage System areused with Biomet's Compress Segmental Femoral ReplacementSystem, the user should refer to the package insert containedwith the Compress components for full prescriptioninformation. | |
| EXPANDABLE INDICATIONSThe Biomet Side Access Distal Femoral Expandable offers atreatment option for patients requiring distal femoralreplacement who have not yet achieved full skeletal maturity(open epiphysis) or patients who require surgery who havesignificant residual leg length discrepancy. Indication for use ofthis device is most commonly tumor resection but could alsoinvolve osteoarthritis; rheumatoid arthritis; correction ofdeformity; and correction or revision of unsuccessfulosteotomy, arthrodesis or previous joint replacement. | |
| The devices are single use implants intended for implantationwith 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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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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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.
§ 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.