(88 days)
Not Found
Not Found
No
The description focuses on the mechanical components and modularity of a prosthetic system for bone replacement. There is no mention of AI or ML in the intended use, device description, or any of the other sections.
Yes
The device is described as a replacement for parts of the femur and tibia, used in cases of metastatic diseases, degenerative joint disease, and trauma, which are all conditions that would require medical intervention for treatment or restoration of function.
No
The "Intended Use / Indications for Use" section states that the MOST System is intended to replace parts of the femur and/or tibia in cases requiring extensive resection and restoration. It is a prosthetic device for repair and replacement, not for diagnosing conditions. The "diagnostic indications for use" refer to the medical conditions for which the device is used, not that the device performs diagnosis itself.
No
The device description clearly outlines multiple physical components made of materials like titanium, indicating it is a hardware-based 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the MOST System is used for the replacement of bones (femur and tibia). This is a surgical implant, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use describes the surgical procedures and conditions for which the implant is used (e.g., replacing bone due to tumors, degenerative joint disease, or trauma). This is a therapeutic use, not a diagnostic one.
The device is a surgical implant used for orthopedic reconstruction.
N/A
Intended Use / Indications for Use
The MOST System is intended to replace the proximal, distal or total femur and/or the proximal tibla, especially in odoco the rouve also include replacement of the restoration. Replacement of the usities with neelssary Proximal femoral replacement components are available for press-fit or cemented applications. replacement components are available in a proximal tible are Components used for replacemont of the distances for use of the MOST include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, 1. metastatic discases (c.g., octoboarders), and replacement(s) of the proximal and/or distal femur and/or proximal tibia;
- patient conditions of non-inflammatory degenerative joint disease (NIDJD), 2. patient conditions of non inflammatory and inflammatory (IJD), e.g. rheumatoid e.g., avascular necrosis, octobar.mn.org.inn.its) and replacement(s) of the proximal and/or distal femur and/or proximal tibia; and
- revision cases requiring resection(s) and replacement(s) of the proximal, distal 3. or total femur and/or proximal tibia.
Product codes (comma separated list FDA assigned to the subject device)
KRO, LZO
Device Description
The MOST Options System (MOST) is used for the replacement of the proximal, distal or total femur and/or the proximal tibia. Replacement of the distal femur would also include replacement of the proximal tibia and possible resurfacing of the patella, if necessary. Unlike primary hip and knee systems, this system can be used where extensive femoral and/or tibial resection and restoration is required (e.g., oncology cases). Modularity of the system allows for the resection of varying amounts of the femur and the proximal tibia (and patella, if necessary) before implantation. A total replacement is possible in cases where no part of the femur can be salvaged. Moreover, the system provides additional options for revision or severe bone loss of the tibia. The components of the MOST System include:
- . a distal femoral replacement (Condylar End or Hinged Femur) which mates with a tibial component via a hinge type mechanism (Hinge-Kit or 4mm Hinge Kit):
- a proximal femur replacement that is available in two designs to address the . presence or absence of the greater trochanter;
- intramedullary (I/M) stems with Cancellous Structured Titanium™ (CSTi™) and . MOST segments which will be used in conjunction with the proximal and distal femoral replacements, the Proximal Tibia and the MOST Revision Stem Adapter;
- an all poly patella; ●
- a proximal tibia replacement (Proximal Tibia or Hinged Tibia) which mates with the . Proximal Tibia Insert and Hinged Tibia Insert, respectively and features a distal female taper for attachment of a MOST Revision Stem Adapter, Sulzer Revision Stems or Hinged Tibia Stem Plug (Hinged Tibia only);
- femoral and tibial spacers for use in conjunction with the Hinged Femur and Hinged . Tibia, respectively to augment uni-compartmental or bi-compartmental defects; and
- revision stem adapter with and without CSTi coating used to convert the MOST . taper to the Sulzer taper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal, distal or total femur and/or the proximal tibia.
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)
Not Found
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.
Not Found
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.
Not Found
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
§ 888.3510 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.
0
K013031
page 1 of 2
510(k) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics MOST Options™ System
| Manufacturer: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9900 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|
| Date: | September 7, 2001 |
| Contact Person: | Frances E. Harrison, RAC
Senior Regulatory Affairs Specialist |
| Classification Name: | Knee joint femorotibial metal/polymer constrained cemented
prosthesis - 21 CFR Part 888.3510 |
| | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis - 21 CFR Part 888.3353 |
| Common/Usual Name: | Total Hinged Knee for Total Knee Replacement
Femorotibial Prosthesis |
| Trade/Proprietary Name: | MOST Options™ System (MOST) |
PRODUCT DESCRIPTION
The MOST Options System (MOST) is used for the replacement of the proximal, distal or total femur and/or the proximal tibia. Replacement of the distal femur would also include replacement of the proximal tibia and possible resurfacing of the patella, if necessary. Unlike primary hip and knee systems, this system can be used where extensive femoral and/or tibial resection and restoration is required (e.g., oncology cases). Modularity of the system allows for the resection of varying amounts of the femur and the proximal tibia (and patella, if necessary) before implantation. A total replacement is possible in cases where no part of the femur can be salvaged. Moreover, the system provides additional options for revision or severe bone loss of the tibia. The components of the MOST System include:
- . a distal femoral replacement (Condylar End or Hinged Femur) which mates with a tibial component via a hinge type mechanism (Hinge-Kit or 4mm Hinge Kit):
- a proximal femur replacement that is available in two designs to address the . presence or absence of the greater trochanter;
- intramedullary (I/M) stems with Cancellous Structured Titanium™ (CSTi™) and . MOST segments which will be used in conjunction with the proximal and distal femoral replacements, the Proximal Tibia and the MOST Revision Stem Adapter;
- an all poly patella; ●
1
- a proximal tibia replacement (Proximal Tibia or Hinged Tibia) which mates with the . Proximal Tibia Insert and Hinged Tibia Insert, respectively and features a distal female taper for attachment of a MOST Revision Stem Adapter, Sulzer Revision Stems or Hinged Tibia Stem Plug (Hinged Tibia only);
- femoral and tibial spacers for use in conjunction with the Hinged Femur and Hinged . Tibia, respectively to augment uni-compartmental or bi-compartmental defects; and
- revision stem adapter with and without CSTi coating used to convert the MOST . taper to the Sulzer taper.
SPECIFIC DIAGNOSTIC INDICATIONS
Components of the MOST System are intended to replace the proximal, distal or total femur and/or the proximal tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use of the MOST include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone . tumors ) and trauma requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur and/or proximal tibia;
- patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., . avascular necrosis, osteoarthritis and inflammatory (IJD), e.g. rheumatoid arthritis, requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur and/or proximal tibia; and
- revision cases requiring resection(s) and replacement(s) of the proximal, distal or total . femur and/or proximal tibia.
SUBSTANTIAL EQUIVALENCE
The MOST Options System is similar to the following commercially available devices in terms of materials, general design features, and intended uses:
- Sulzer Orthopedics MOST™ System .
- Johnson & Johnson S-ROM® Noiles™ Rotating Hinge Knee System .
- Howmedica Osteonics® Modular Rotating Hinge Knee (MRS) .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2001
Ms. Frances E. Harrison, RAC Senior Regulatory Affairs Specialist Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
Re: K013031
Trade/Device Name: MOST Options System Regulation Number: 21 CFR 888.3510; 21 CFR 888.3353 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis; Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class: II Product Code: KRO, LZO Dated: September 7, 2001 Received: September 10, 2001
Dear Ms. Harrison:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovious your becemined the device is substantially equivalent (for the indications ferenced above and have sure) to legally marketed predicate devices marketed in interstate for use stated in the enorosals) to 10gains actual device Amendments, or to commerce prior to rias 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercesses maines 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 If your device is olassined (600 a00 voyals. Existing major regulations affecting your device can may be subject to back as back as a submit ons, 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 lease of advised that I Drivisan that your device complies with other requirements of the Act that I Dr Has made a wond regulations administered by other Federal agencies. You must of any I vith 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 OF IT in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maing of substantial equivalence of your device to a legally premaired notification. The PDF intelling of easification 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 IT you desire specific ad roo for your witto diagnostic devices), please contact the Office of additionally 21 CHC Far 007.10 Tor questions on the promotion and advertising of Compliance at (301) 594-1699 of Compliance at (301) 594-4639. Also, please note the your devices, proced volisbranding by reference to premarket notification" (21CFR Part 807.97). regulation on this contrass on your responsibilities under the Act may be obtained from the Outcr general miormation turers, 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,
Sincerely yours,
Mark McMillan
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
4
| 510(k) Number (if known): | K013031 |
|---|---|
| Device Name: | MOST System |
Indications for Use:
The MOST System is intended to replace the proximal, distal or total femur and/or The MOST System is intendou to rep that require extensive resection and the proximal tibla, especially in odoco the rouve also include replacement of the restoration. Replacement of the usities with neelssary Proximal femoral
proximal tibia and possible resurfacing of the patella, if necessary Proximal femoral proximal tible and possible for press-fit or cemented applications.
replacement components are available for press-fit or cement within are replacement components are available in a proximal tible are Components used for replacemont of the distances for use of the MOST include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, 1. metastatic discases (c.g., octoboarders), and replacement(s) of the proximal and/or distal femur and/or proximal tibia;
- patient conditions of non-inflammatory degenerative joint disease (NIDJD), 2. patient conditions of non inflammatory and inflammatory (IJD), e.g. rheumatoid e.g., avascular necrosis, octobar.mn.org.inn.its) and replacement(s) of the proximal and/or distal femur and/or proximal tibia; and
- revision cases requiring resection(s) and replacement(s) of the proximal, distal 3. or total femur and/or proximal tibia.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
for Mark N. Melkerson
(Division Sign-Off)
Division of Ge
and Neurologic Devices
510(k) Number K013031
Prescription Use X OR Over-the Counter Use __
(Optional Format 1-2-96)