(29 days)
Not Found
Not Found
No
The document describes a knee implant system and does not mention any AI or ML components.
Yes
The device is intended for the replacement of parts of the knee joint due to conditions like degenerative arthritis or failed previous surgeries, which clearly indicates its use in treating medical conditions to alleviate symptoms or restore function.
No.
The document describes a knee replacement system intended for surgical implantation to treat existing conditions, not to diagnose them.
No
The device description clearly states it consists of "sterile, single-use components intended for replacement of the femoral side of the patellofemoral joint and/or the condyle region(s) of the femoral joint," indicating it is a physical implant, 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Stryker® Compartmental Knee System is a system of implantable components intended for the surgical replacement of parts of the knee joint. This is a surgical device, not a diagnostic test performed on a sample outside the body.
The text describes a medical device used for surgical intervention and treatment, not for diagnosing a condition using in vitro methods.
N/A
Intended Use / Indications for Use
Intended Use: The Stryker® Compartmental Knee System Line Extension consists of sterile, single-usc devices intended for replacement of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The Stryker® Compartmental Knee System Line Extension includes Triathlon® PKR femoral condyle regions for cither the right or left knee.
Indications for Use: The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or unicondylar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different components of the Stryker® Compartmental Knee System include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the following conditions:
- . Degenerative arthritis in the distal femur and patella.
- Patients with a history of patellar dislocation or patella fracture, .
- . Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists,
- . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knec prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, . or
- Where bone stock is of poor quality or inadequate for other reconstructive techniques . as indicated by deficiencies of the femoral condvle/tibial plateau.
These components are single use only and are intended for implantation with bone cement only.
Product codes
87 NPJ, 87 KRR, 87 HSX, 87 HRY
Device Description
The Stryker® Compartmental Knee System consists of sterile, single-use components intended for replacement of the femoral side of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The system includes patellofemoral, femoral, and tibial components from currently marketed Howmedica Ostconics' knee systems for patellofemoral and unicondylar arthroplasty. The system allows the physician to choose the most appropriate option to treat the patient with patellofemoral arthroplasty and/or unicondylar arthroplasty as needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, distal femur and patella, femorotibial or patellofemoral regions of the knee, femoral condyle/tibial plateau
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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
OCT 3 - 2008
Summary of Safety and Effectiveness Stryker® Compartmental Knee System Line Extension
| Proprietary Name: | Stryker® Compartmental Knee System Line Extension |
|---|---|
| Common Name: | Knee Prosthesis |
| Classification Name and Reference: | Knee joint femortotibial polymer/metal semi constrained cemented prosthesis. 21 CFR §888.3530 |
| Knee joint patellofemoral polymer/metal semi constrained cemented prosthesis. 21 CFR §888.3540 | |
| Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. 21 CFR §888.3520 | |
| Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. 21 CFR §888.3530 | |
| Device Product Code: | 87 NPJ, 87 KRR, 87 HSX, 87 HRY |
| For Information Contact: | Francisco Haro, Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5493 Fax: (201) 831-6038 |
| Date Summary Prepared: | September 3, 2008 |
Description:
The Stryker® Compartmental Knee System consists of sterile, single-use components intended for replacement of the femoral side of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The system includes patellofemoral, femoral, and tibial components from currently marketed Howmedica Ostconics' knee systems for patellofemoral and unicondylar arthroplasty. The system allows the physician to choose the most appropriate option to treat the patient with patellofemoral arthroplasty and/or unicondylar arthroplasty as needed.
1
Intended Use:
The Stryker® Compartmental Knee System Line Extension consists of sterile, single-usc devices intended for replacement of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The Stryker® Compartmental Knee System Line Extension includes Triathlon® PKR femoral condyle regions for cither the right or left knee.
Indications for Use:
The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or unicondylar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different components of the Stryker® Compartmental Knee System include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the following conditions:
- . Degenerative arthritis in the distal femur and patella.
- Patients with a history of patellar dislocation or patella fracture, .
- . Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists,
- . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knec prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, . or
- Where bone stock is of poor quality or inadequate for other reconstructive techniques . as indicated by deficiencies of the femoral condvle/tibial plateau.
These components are single use only and are intended for implantation with bone cement only.
2
Substantial Equivalence:
The device is substantially equivalent to its predicates for patellofemoral arthroplasty and femorotibial arthroplasty in regards to intended use, design, materials, and operational principles. The analysis demonstrated that the components from these systems are compatible when used for patellofemoral and/or femorotibial replacement.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined strands and a wing-like structure above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Public Health Service
OCT 3 - 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Francisco Haro Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K082567
Trade/Device Name: Stryker® Compartmental Knee System Line Extension Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: IIRY, NPJ, HSX, KRR Dated: September 3, 2008 Received: September 4, 2008
Dear Mr. Francisco Haro:
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 l'ood, 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 gencral 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.
4
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mikkelson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K082567 510(k) Number (if known):
Device Name: Stryker® Compartmental Knec System Line Extension
Indications for Use;
The Stryker® Compartmental Knee System line extension is intended for use in cemented patellofemoral and/or unicondylar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different components of the Stryker® Compartmental Knec System line extension include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the following conditions:
- . Degenerative arthritis in the distal femur and patella,
- . Patients with a history of patellar dislocation or patella fracture,
- . Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists,
- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis,
- . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, . or
- . Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
These components are single use only and are intended for implantation with bone cement.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Mark Mill
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of General, Restorative, and Neurological Devices
Infection Control, Dental Devices
510(k) Number:
510(k) Number