(159 days)
No
The document describes orthopedic implants and their indications for use, focusing on mechanical properties and material characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as an 'Orthopaedic Salvage System' used for conditions like avascular necrosis, osteoarthritis, tumor resections, and trauma, clearly indicating its use in treating medical conditions.
No
This device is a surgical implant (prosthesis components) for limb salvage reconstruction, used in treatment rather than diagnosis.
No
The device description clearly states the new devices are "additional components to Biomet's Orthopaedic Salvage System (OSS)" and lists physical components like "distal femoral component, proximal femoral component, proximal tibial sleeve, diaphyseal segment, splined stem, diaphyseal augment and metaphyseal augment." These are hardware components, not software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states the devices are "additional components to Biomet's Orthopaedic Salvage System (OSS)" and include things like "distal femoral component, proximal femoral component, proximal tibial sleeve, diaphyseal segment, splined stem, diaphyseal augment and metaphyseal augment." These are all components intended for surgical implantation to replace or augment bone structures.
- Intended Use/Indications for Use: The indications listed are for treating conditions like painful joints, deformities, tumor resections, fractures, and failed joint replacements. These are all conditions treated through surgical intervention, not through laboratory testing of samples.
The device is an orthopedic implant system used in surgical procedures, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
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.
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:
-
- 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.
Product codes
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 distal femoral component, proximal femoral component, proximal tibial sleeve, diaphyseal segment, splined stem, diaphyseal augment and metaphyseal augment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal and Distal Femoral Reconstruction, Tibial Reconstruction.
Indicated Patient Age Range
Small adults and adolescents (12-21 years) for Biomet OSS Reduced size (RS) components.
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 Fatique Testing
Device Static Disassociation Testing
Tensile Properties Testing
Material Characterization for OsseoTi
Cleaning
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K002757, K052685, K123501, K051479/K021260, K110940
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
1
(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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
Indications for Use
510(k) Number (if known) K141331
Device Name
Biomet Orthopedic Salvage System (OSS) Line Extension
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.
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:
-
- 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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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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 | (574) 372-1761 |
| Fax number | (574) 372-1683 |
| Establishment | |
| Registration Number | 1825034 |
| Name of contact person | Tracy Bickel Johnson, RAC |
| Date prepared | 22 August 2014 |
| Name of device | |
| Trade or proprietary | |
| name | Biomet Orthopaedic Salvage System (OSS) |
| Common or usual | |
| name | Knee/Hip Implants |
| Classification name / | |
| Regulation | Prosthesis, hip, semi-constrained, metal/polymer, porous |
| uncemented (21 CFR § 888.3350); | |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 | |
| CFR § 888.3350); | |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, | |
| Metal/Polymer (21 CFR § 888.3510) | |
| Classification panel | Orthopedic |
| Product Code(s) | LPH; JDI; KRO |
| Legally marketed device(s) | |
| to which equivalence is | Biomet Orthopaedic Salvage System (K002757, K052685, |
| K123501); | |
| claimed | 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 Item: Biomet Reconstructive Wedges (K122770) | |
| Reference Item: Regenerex Sleeve Augments (K072336) | |
| Reason for 510(k) | |
| submission | New device |
| 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 distal femoral | |
| component, proximal femoral component, proximal tibial sleeve, | |
| diaphyseal segment, splined stem, diaphyseal augment and | |
| metaphyseal augment. | |
| Intended use of the device | Proximal and Distal Femoral Reconstruction, Tibial |
| Reconstruction. | |
| Indications for use | 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. |
| Summary of the Technologies | 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. |
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
Shipping Address:
56 East Bell Drive
Warsaw, IN 46582
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Image /page/5/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 right of the word.
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Image /page/6/Picture/0 description: The image shows the logo for Biomet. The logo is in a sans-serif font and is all uppercase. The letters are all connected and have a thick, blocky appearance. There is a registered trademark symbol in the upper right corner of the logo.
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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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 present to the right of the letter "T". The word is in a gray color, and the background is white.
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.