(30 days)
No
The document describes a mechanical implant (a metal rod) and its intended uses and compatibility with other components. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is indicated for various medical conditions such as avascular necrosis, osteoarthritis, traumatic arthritis, tumor resections, and revision of failed joint arthroplasty, all of which aim to treat or alleviate a medical condition.
No.
The device description clearly states it is a "metal rod that is inserted into the IM canal of a femur" and is used for "replacement" and "correction" of various conditions, indicating it is an implantable medical device for treatment, not diagnosis. The "Intended Use / Indications for Use" section lists conditions for which the device is used, not conditions it diagnoses.
No
The device description clearly states it is a "metal rod" and describes its physical characteristics and compatibility with other hardware components. This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "metal rod that is inserted into the IM canal of a femur" and is used to connect components for joint replacement and reconstruction. This is an implantable surgical device.
- Intended Use/Indications for Use: The indications listed are for treating musculoskeletal issues like painful joints, deformities, tumor resections, and fractures. These are all conditions treated through surgical intervention, not through laboratory testing of bodily samples.
- Lack of IVD Keywords: The text does not mention any terms related to laboratory testing, samples, analysis, or diagnosis based on biological markers.
Therefore, the device described is a surgical implant, not an In Vitro Diagnostic device.
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.
- 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:
-
- 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 turnor 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 Biomet Compress.
Product codes (comma separated list FDA assigned to the subject device)
JDI, KRO, JWH
Device Description
The OSS/Arcos IM Total Femur Rod is, in simplest terms, a metal rod that is inserted into the IM canal of a femur and connects a proximal femoral component to a distal femoral component. The aforementioned femoral components are secured to the rod by both a Morse taper and a screw; the proximal end features an "Arcos" taper while the distal end is an "OSS" taper. The Arcos taper is the same as that utilized by the devices in K090757 while the OSS taper is identical to that utilized by the predicate device.
The rods are slightly bowed to mimic the natural femur and find appropriate alignment. All rods have a diameter of 14 mm and are available in 1 cm length increments from 20 cm to 30 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, Hip, Knee, Proximal Femur, Proximal Tibia
Indicated Patient Age Range
Adults and adolescents (12-21 years)
Intended User / Care Setting
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)
Mechanical testing in support of the Arcos taper and proximal screw was previously supplied in K090757. These tests were performed on the worst-case Arcos constructs; as the OSS/Arcos IM Total Femur Rod does not present a new worst-case, this testing is sufficient show the subject device is as safe and effective as the predicate.
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.
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.
K912712, K090757, K141331, K140509
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol that resembles a stylized human figure or a caduceus, possibly representing health and well-being. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2015
Biomet Incorporated Mr. Bryan McMahon Regulatory Affair Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K152621
Trade/Device Name: OSS/Acros IM Total Femur Rod Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, KRO, JWH Dated: September 10, 2015 Received: September 14, 2015
Dear Mr. McMahon:
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 (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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name OSS/Arcos IM Total Femur Rod
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:
-
- 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 turnor 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 Biomet Compress.
3
Image /page/3/Picture/0 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The color of the text is a dark gray, and the background is white. The overall impression is clean and modern.
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the OSS/Arcos IM Total Femur Rod 510(k) premarket notification.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bryan M. McMahon
Regulatory Affairs Specialist |
| Date: | October 12, 2015 |
| Subject Device: | Trade Name: OSS/Arcos IM Total Femur Rod
Common Name: Oncology, Salvage Hip/Knee
Classification Name:
• JDI- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
(21 CFR 888.3350)
• KRO- Prosthesis, Knee, Femorotibial, Constrained, Cemented,
Metal/Polymer (21 CFR 888.3510)
• IWH- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained |
Legally marketed devices to which substantial equivalence is claimed:
- K033871, K123501 IM Total Femur Biomet. Inc ●
- K912712, K090757 - Modular Hip - Biomet, Inc. (Taper Connection)
- K141331, K140509 - Biomet Orthopedic Salvage System - Biomet, Inc. (Indications)
Cemented, Polymer/Metal/Polymer (21 CFR 888.3560)
Device Description
The OSS/Arcos IM Total Femur Rod is, in simplest terms, a metal rod that is inserted into the IM canal of a femur and connects a proximal femoral component to a distal femoral component. The aforementioned femoral components are secured to the rod by both a Morse taper and a screw; the proximal end features an "Arcos" taper while the distal end is an "OSS" taper. The Arcos taper is the same as that utilized by the devices in K090757 while the OSS taper is identical to that utilized by the predicate device.
The rods are slightly bowed to mimic the natural femur and find appropriate alignment. All rods have a diameter of 14 mm and are available in 1 cm length increments from 20 cm to 30 cm.
Image /page/3/Picture/12 description: In the image, a bone is shown with metal attachments on both ends. The bone is long and slender, with a slightly curved shape. The metal attachments are silver and appear to be connected to the bone with screws or bolts. The bone and metal attachments are likely part of a medical device or implant, possibly for orthopedic surgery. The image is well-lit and the details of the bone and metal attachments are clearly visible.
Figure 7.1: An example OSS/Arcos IM Total Femur Rod construct inside the IM canal of a femur.
4
The device is compatible with Biomet's Arcos proximal bodies and OSS distal femoral components.
Intended Use and 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. 2.
-
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Ligament deficiencies. 4.
-
- Tumor resections.
- Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the 6. 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:
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
-
- Tumor resections.
- Revision of previously failed total joint arthroplasty. 3.
-
- 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
5
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.
Summary of Technological Characteristics
The new devices are a modification to the predicate device (K033871, K123501) in the following ways:
- The proximal taper geometry is being modified
- The proximal screw packaged with the device is changing
All other technological characteristics remain unchanged.
Summary of Performance Data
Mechanical testing in support of the Arcos taper and proximal screw was previously supplied in K090757. These tests were performed on the worst-case Arcos constructs; as the OSS/Arcos IM Total Femur Rod does not present a new worst-case, this testing is sufficient show the subject device is as safe and effective as the predicate.
Substantial Equivalence Conclusion
The proposed and predicate IM Total Femur (K033871, K123501) devices have the same intended use and indications for use (K141331, K14050) and Taper Connection References (K912712, K090757). The proposed design changes do not alter the fundamental scientific technology shared by both the proposed and predicate IM Total Femur devices. The information provided in this submission demonstrates that the proposed device is as safe and effective as the predicate and does not raise different questions of safety and effectiveness than the predicate. Therefore, the proposed OSS IM Total Femur Rod is substantially equivalent to the cited predicate device(s).