(29 days)
Not Found
No
The document describes a system of orthopedic implants and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a joint replacement system (Orthopedic Salvage System - OSS) comprised of physical implants used in surgical procedures to replace or reconstruct bones and joints, which is not typically classified as a therapeutic device in the sense of providing treatment through non-invasive means, energy, or chemical action. It is a prosthetic device for structural replacement.
No
The device is described as an orthopedic implant system used for joint replacement and salvage, not for diagnosing conditions. Its intended use is for treatment, not for identifying diseases or conditions.
No
The device description explicitly states that the device is a system of "single use implants," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description: The description clearly states that the OSS bodies are "single use implants" and are for "cemented use only." This means they are surgically implanted inside the body.
- Intended Use: The intended uses listed are all related to surgical procedures and the treatment of musculoskeletal conditions within the body.
This device is an orthopedic implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OSS bodies are indicated for cemented use only in cases of:
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
-
- Correction of varus, valgus, functional or post traumatic deformity
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous ioint 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
-
- Trauma
-
- Revision of previously failed total joint arthroplasty
Product codes
KRO, JDI
Device Description
The Orthopedic Salvage System- OSS offers a variety of component options for the treatment of patients that require proximal femoral, total femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur. These devices are single use implants. These devices are for cemented use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Proximal femur, Total femur, Total femoral, Proximal tibial
Indicated Patient Age Range
Not Found
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)
Non-Clinical Testing: An engineering analysis was performed on the modified and predicate devices comparing their profiles. The results indicated that the device was functional within its intended use.
Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device 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 word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and have a blocky, geometric design. The letters are arranged horizontally, with each letter clearly separated from the others. The word is likely a logo or brand name.
007 8 7 2002
510(k) Summary
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
|---|---|
| Contact Person: | Allison Koskey, Regulatory Affairs Specialist |
| Proprietary Name: | Orthopedic Salvage System - OSS |
| Common Name: | OSS Bodies |
| Classification Name: | -Prosthesis, Hip, semi-constrained, metal/polymer, cemented |
| (888.3350, 87 JDI) | |
| -Prosthesis, Knee, femorotibial, constrained, cemented, metal/polymer | |
| (888.3510, 87 KRO) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Orthopedic Salvage System- OSS (K002757)
Device Description: The Orthopedic Salvage System- OSS offers a variety of component options for the treatment of patients that require proximal femoral, total femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.
Indications for Use:
- 1 ) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
- Correction of varus, valgus, functional or post traumatic deformity 2)
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 3)
-
- Ligament deficiencies
- Turnor resections 5)
- Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal 6) femur with head involvement, unmanageable using other techniques
-
- Trauma
-
- Revision of previously failed total joint arthroplasty
These devices are single use implants.
These devices are for cemented use only.
Summary of Technologies: The designs, intended use, contraindications, and design specifications of the subject components are similar or identical to their predicate counterparts. This submission allows for additional sizing options for the OSS bodies.
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Formerly known as the Oncology Salvage System- OSS All trademarks are property of Biomet, Inc.
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Image /page/1/Picture/1 description: The image shows the word "BIOMET" in a stylized, blocky font. The letters are bold and outlined in black, with a white fill. The overall design is simple and geometric, giving the word a strong and modern appearance.
Non-Clinical Testing: An engineering analysis was performed on the modified and predicate devices comparing their profiles. The results indicated that the device was functional within its intended use.
Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing.
- Formerly known as the Oncology Salvage System- OSS All trademarks are property of Biomet, Inc.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 2005
Allison Koskey Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K052685
Trade/Device Name: Orthopedic Salvage System - OSS Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Codes: KRO, JDI Dated: September 26, 2005 Received: September 28, 2005
Dear Ms. Koskey:
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 for ass saled in the exerces, 1976, the enactment date of the Medical Device Amendments, or 10 conniner 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). and Cosmetic Free (110) has the device, subject to the general controls provisions of the Act. The rou may a controls provisions of the Act include requirements for annual registration, listing of general obtable provinciting practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it rr your device is elaborned toontrols. Existing major regulations affecting your device can be found in the Codc 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 I rease be advisou that I bristian that your device complies with other requirements of the Act that + Dr Has Intactions and regulations administered by other Federal agencies. You must or any I edetal statuated and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N 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.
3
Page 2 - Ms. Allison Koskey
This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow your to organ finding of substantial equivalence of your device to a legally premits tourication. The PPF midning of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific acriously 3 at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Computance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet and odress http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_KO526 85
Device Name: Orthopedic Salvage System - OSS
Indications For Use: The OSS bodies are indicated for cemented use only in cases of:
-
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
-
- Correction of varus, valgus, functional or post traumatic deformity
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous ioint 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
-
- Trauma
-
- Revision of previously failed total joint arthroplasty
Prescription use __X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use 1 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number X052685
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