(13 days)
No
The document describes a knee implant system and a change to its labeling (adding a contraindication and minor clarifications). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the physical components and their intended use.
Yes
The device is a knee prosthesis intended to alleviate symptoms and address physical limitations caused by joint disease of the knee, which classifies it as having a therapeutic effect.
No
The document describes an orthopedic implant system (Triathlon® PKR System) for joint replacement in the knee, which is a therapeutic device, not a diagnostic one. Its intended use is to treat painful arthritis and enable revision surgeries, not to diagnose conditions.
No
The device description explicitly states that the subject devices are "Triathlon® PKR System X3® Tibial Inserts," "Triathlon® PKR Unicompartmental Femoral Component," and "Triathlon® PKR Unicompartmental Tibial Baseplate," which are physical implantable components for knee replacement surgery.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating knee joint disease. This involves direct implantation into the body, not testing of samples taken from the body.
- Device Description: The device components are described as parts of a knee prosthesis (femoral component, tibial baseplate, tibial inserts). These are physical implants.
- Anatomical Site: The anatomical site is the knee, which is an internal body part where the device is implanted.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), using reagents, 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 diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant used to replace damaged joint components.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
HSX, HRY, KRR, NPJ
Device Description
The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E) are unchanged since the last premarket notification for the devices in K180612. The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are unchanged since the last premarket notification for the devices in K172326.
The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E), Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are collectively referred to throughout this submission as the subject devices.
The purpose of this "Change Being Effected" premarket notification is to add a contraindication for the Triathlon® PKR X3® Tibial Inserts, Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate. Additionally, minor clarifications are being made to the labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
No additional testing was conducted for this submission, as the only changes being made are the addition of a contraindication and minor labeling clarifications. Testing performed in the previously cleared premarket notifications is applicable to this submission.
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.
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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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March 1, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
Howmedica Osteonics Corp aka Stryker Orthopaedics Allison Byrne Regulatory Affairs Specialist 325 Corporate Dr. Mahwah, New Jersey 07430
Re: K203099
Trade/Device Name: Triathlon PKR System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX, HRY, KRR, NPJ
Dear Allison Byrne:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 27, 2020. Specifically, FDA is updating this SE Letter to include all product codes (HSX, HRY, KRR, NPJ) associated with the submission as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ting Song, Ph.D., R.A.C., OHT6: Office of Orthopedic Devices, 301-796-7677, Ting.Song@fda.hhs.gov.
Sincerely,
Ting Song -S
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the Department of Health & Human Services logo. The logos are aligned horizontally.
October 27, 2020
Howmedica Osteonics Corp., aka Stryker Orthopaedics Allison Byrne Regulatory Affairs Specialist 325 Corporate Dr. Mahwah, New Jersey 07430
Re: K203099
Trade/Device Name: Triathlon PKR System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: October 12, 2020 Received: October 14, 2020
Dear Allison Byrne:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/6 description: The image shows a digital signature. The signature is from Peter G. Allen -S. The date of the signature is 2020.10.27, and the time is 15:54:32 -04'00'.
for Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203099
Device Name Triathlon PKR System
Indications for Use (Describe)
· 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
· 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 intended for implantation with bone cement.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5: 510(k) Summary K203099 page 1 of 4
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510(k) Summary K203099 page 2 of 4
| Sponsor | Howmedica Osteonics Corp aka Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Allison Byrne
Regulatory Affairs Specialist
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
(201) 831-5969 |
| Alternate Contact | Margaret Klippel
Chief Regulatory Affairs Specialist
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
(201) 831-5559 |
| Date Prepared: | October 12th, 2020 |
| Proprietary Name: | Triathlon PKR System |
| Common Name: | Partial Knee Joint Replacement |
| Classification Name: | 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)
Knee joint patellofemoral polymer/metal semi-constrained cemented
prosthesis (21 CFR § 888.3540)
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis (21 CFR § 888.3560) |
| Product Codes: | HSX; HRY; KRR; NPJ |
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
- Triathlon® PKR System X3® Tibial Inserts, 5630-G-XXX-E (K180612) ●
- Triathlon® PKR System X3® Tibial Inserts, 5630-G-XXX (K172326) .
- Triathlon® PKR Unicompartmental Femoral Component (K172326) ●
- Triathlon® PKR Unicompartmental Tibial Baseplate (K172326) ●
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K203099 page 3 of 4
Subject devices Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate were submitted previously in K082567 and K071881.
Device Description: The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E) are unchanged since the last premarket notification for the devices in K180612. The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are unchanged since the last premarket notification for the devices in K172326.
The subject Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX-E), Triathlon® PKR System X3® Tibial Inserts (5630-G-XXX), Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate are collectively referred to throughout this submission as the subject devices.
The purpose of this "Change Being Effected" premarket notification is to add a contraindication for the Triathlon® PKR X3® Tibial Inserts, Triathlon® PKR Unicompartmental Femoral Component, and Triathlon® PKR Unicompartmental Tibial Baseplate. Additionally, minor clarifications are being made to the labeling.
Intended Use:
The intended use of the subject devices is identical to the intended use specified in the 510(k) clearances for their respective predicate device. The subject devices are intended for use in Primary or Revision Partial Knee Arthroplasty.
Indications for Use:
- . 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
- . 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 intended for implantation with bone cement.
Summary of Technological Characteristics:
Neither the addition of the contraindication for which this "Change Being Effected" premarket notification is being submitted, nor the minor labeling clarifications, will change the technological characteristics of the subject devices.
Non-Clinical or Clinical Testing:
No additional testing was conducted for this submission, as the only changes being made are the addition of a contraindication and minor labeling clarifications. Testing performed in the previously cleared premarket notifications is applicable to this submission.
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Conclusion:
The subject devices are substantially equivalent to their identified predicate device. The subject devices are identical in intended use, indications, design, technological characteristics and operational principles as described in the last premarket notification for the subject devices. The only changes made to the subject devices are the added contraindication and minor labeling clarifications.