(88 days)
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No
The document describes a mechanical orthopedic implant system and does not mention any AI or ML components or functionalities.
Yes.
The device is an implantable system used to replace significant portions of bone due to various diseases and conditions, which directly addresses therapeutic intervention for these ailments.
No
The document explicitly states the device is "intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia" and describes it as a "Proximal Tibial Replacement system." This indicates it is a therapeutic or reconstructive device, not a diagnostic one. While it lists "Specific diagnostic indications for use," these refer to the conditions for which the device is used (e.g., metastatic diseases), not that the device performs diagnosis itself.
No
The device description explicitly states it consists of physical components like a titanium tibial replacement, polyethylene tibial bearing component, stems, and segments, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing portions of bones (femur and tibia) and joints (hip and knee). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a system of titanium and polyethylene components designed for implantation during surgery. This aligns with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a physical implant used to replace damaged or diseased bone and joint structures.
N/A
Intended Use / Indications for Use
The Orthogenesis LPS is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur;
- patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
- revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.
The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
87 KRO
Device Description
The Orthogenesis LPS Proximal Tibial Replacement system is designed to be implanted for the The Orthogenesis Er of Proximal Troul'se primary knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). It consists of a titanium tibial replacement, a polyethylene tibial bearing component, Orthogenesis LPS stems and Segments.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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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KO11810
510(k) Summary Orthogenesis LPS Proximal Tibial Replacement
DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581
A. Contact Person:
Janet G. Johnson, RAC Group Leader, Regulatory Submissions (219) 371-4907
B. Device Information:
| Proprietary Name: | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial Bearing |
|---|---|
| Common Name: | Proximal Tibial Replacement Prosthesis |
| Classification Name and Regulatory Class: | Knee joint femorotibial metal/polymer constrained cemented prosthesis: Class II per 21 CFR §888.3510 |
| Product Code: | 87 KRO |
C. Indications for Use:
The Orthogenesis LPS is intended for use in replacement of the mid-shaft or intercalary portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:
- . metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
- . patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur;
- patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
- revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.
The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.
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D. Device Description:
The Orthogenesis LPS Proximal Tibial Replacement system is designed to be implanted for the The Orthogenesis Er of Proximal Troul'se primary knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). It consists of a titanium tibial replacement, a polyethylene tibial bearing component, Orthogenesis LPS stems and Segments.
E. Substantial Equivalence:
The substantial equivalence of the Orthogenesis LPS Proximal Tibial Replacement is substantiated by its I he Subsumian bqur. For use, design, materials, sterilization and packaging to the S-ROM Noiles Rotating Hinge Knee (K896048 and K905810), and the Orthogenesis LPS system.
The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff entwined with two snakes, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
SEP - 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janet G. Johnson Group Leader, Regulatory Submissions DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K011810
Trade Name: Orthogenesis LPS Proximal Tibial Replacement System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: June 8, 2001 Received: June 11, 2001
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Janet G. Johnson
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematics notification " in a classification for 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 and If you desire specific ad 100 to for in vitro diagnostic devices), please contact the Office of additionally 21 OF It Far at 659. Additionally, for questions on the promotion and advertising of Compliance ut (201) 594-1667 - 1ffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation ontined, "Nilocranaing oresponsibilities under the Act may be obtained from the Outler general mioninates, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sus. Wl mo
f
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO11810 Orthogenesis LPS Proximal Tibial Replacement
Indications for Use
The Orthogenesis LPS is intended for use in replacement of the mid-shaft or intercalary portion of the I he Orthogellesis LT S is mended for ase in replacement tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) . metastatic unseases (0.g.) osteboard ment(s) of the proximal and/or distal femur;
- requiring extensive resection(o) and systemerative joint disease (NIDJD), e.g. avascular . patient conomons of nominaniatory dogent disease (IJD), e.g., rheumatoid arthritis, requiring necerosis, obteour in the, applacement of the proximal and/or distal femur;
- extents suffering from severe arthropathy of the hip and/or knee that does not respond to any . patients burr therapy or better alternative surgical treatment;
- coniservaire there areau resection(s) and replacements of the proximal, distal or total . femur or proximal tibia.
The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.
(Please do not write below this line - Continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR §801.109) OR
Over-the-Counter Use
SL
(Optional Format 1-2-96)
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K011810
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