(69 days)
No
The document describes a hip implant device and its components, focusing on materials, sterilization methods, and compatibility. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes.
The device is an orthopedic implant for total hip arthroplasty, which is a surgical procedure to alleviate painful, disabling joint disease of the hip. This directly addresses medical conditions and restores function, classifying it as a therapeutic device.
No
The device is a hip implant (Exeter X3 RimFit Cup) used in total hip arthroplasty, which is a treatment for painful and disabling joint disease. It is an orthopedic reconstructive device, not something that diagnoses a condition.
No
The device description clearly outlines physical components made of UHMWPE, stainless steel, and PMMA, which are hardware materials. The submission is for a physical implantable device (acetabular cup) used in hip arthroplasty.
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 total hip arthroplasty, addressing painful and disabling joint disease. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as an acetabular cup, a physical component implanted during surgery. It is made of materials like UHMWPE, stainless steel, and PMMA.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The indications for use for total hip arthroplasty include:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, ● post-traumatic arthritis or late-stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less ● likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as ● cementless fixation, as indicated by deficiencies of the acetabulum.
The Exeter X3 RimFit Cup is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JDI, LZO, JDG, KWY
Device Description
This submission covers the subject Exeter X3 RimFit Cups, terminally sterilized by gas plasma (GP) or ethylene oxide (EtO).
The Exeter X3-GP RimFit Cup, terminally sterilized by gas plasma (GP), was previously cleared in K193429 and K111848. It features three subcomponents: a cup manufactured from X3 UHMWPE, a radiopaque wire manufactured from Rex 734 Stainless Steel (Orthinox), and cement spacers manufactured from SG-10 PMMA.
The Exeter X3-EtO RimFit Cup, terminally sterilized by ethylene oxide (EtO), was previously cleared in K193429. It features three subcomponents: a cup manufactured from X3 UHMWE, a radiopaque wire manufactured from Rex 734 Stainless Steel (Orthinox), and cement spacers manufactured from TS2270 PMMA.
The subject Exeter X3-GP RimFit Cup and Exeter X3-EtO RimFit Cup are compatible for use with Stryker Orthopaedics V40 femoral heads, universal taper femoral heads, and C-Taper femoral heads as previously cleared in K111848.
The purpose of the submission is to modify the labeling to remove a contraindication for obesity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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: Based on the definitions for contraindications and warnings from the FDA Device Labeling Guidance #G91-1, obesity should not be considered a contraindication to total hip arthroplasty, but rather a warning that should be adequately assessed by the surgeon and clearly communicated to the patient. The current subject device labeling already has a warning regarding obesity. Performance testing was not required in support of this labeling modification.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing 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
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February 1, 2022
Howmedica Osteonics Corp., dba Stryker Orthopaedics Lin Song Senior Manager, Regulatory Affairs 325 Corporate Drive Mahwah, New Jersey 07430
Re: K213701
Trade/Device Name: Exeter® X36 RimFit® Cup Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, LZO, JDG, KWY Dated: November 29, 2021 Received: December 1, 2021
Dear Lin Song:
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
1
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,
Limin Sun, Ph.D. Acting 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
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
Indications for Use
510(k) Number (if known) K213701
Device Name Exeter® X3® RimFit ® Cup
Indications for Use (Describe)
The indications for use for total hip arthroplasty include:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, ● post-traumatic arthritis or late-stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. ●
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less ● likely to achieve satisfactory results.
- Where bone stock is of poor quality or inadequate for other reconstructive techniques, such as ● cementless fixation, as indicated by deficiencies of the acetabulum.
The Exeter X3 RimFit Cup is intended for cemented use only.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (6/20)
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510(k) Summary
| Sponsor: | Howmedica Osteonics Corp dba Stryker Orthopaedics |
|---|---|
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Contact Person: | Lin Song |
| Senior Manager, Regulatory Affairs | |
| Howmedica Osteonics Corp | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| lin.song@stryker.com | |
| Phone: (201) 248-0177 | |
| Date Prepared: | January 28, 2022 |
| Proprietary Name: | Exeter® X3® RimFit® Cup |
| Common Name: | Total Hip Prosthesis |
| Classification Name: | Hip joint metal/polymer semi-constrained cemented prosthesis (21 |
| CFR §888.3350) | |
| Hip joint metal/ceramic/polymer, semi-constrained cemented or non- | |
| Porous uncemented (21 CFR §888.3353) | |
| Hip joint Femoral (hemi-hip) metallic cemented or uncemented | |
| prosthesis (21 CFR §888.3360) | |
| Hip joint femora (hemi-hip) metal/polymer cemented or uncemented | |
| prothesis (21 CFR §888.3390) | |
| Product Codes: | JDI, LZO, JDG, KWY |
Legally Marketed Device to Which Substantial Equivalence is Claimed:
- Primary Predicate Device: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (K193429) .
- . Secondary Predicate Device: Exeter X3 RimFit Acetabular Cup (K111848)
- Reference Device: Zimmer ZCA All-Poly Acetabular Cups (K191449) ●
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Device Description
This submission covers the subject Exeter X3 RimFit Cups, terminally sterilized by gas plasma (GP) or ethylene oxide (EtO).
The Exeter X3-GP RimFit Cup, terminally sterilized by gas plasma (GP), was previously cleared in K193429 and K111848. It features three subcomponents: a cup manufactured from X3 UHMWPE, a radiopaque wire manufactured from Rex 734 Stainless Steel (Orthinox), and cement spacers manufactured from SG-10 PMMA.
The Exeter X3-EtO RimFit Cup, terminally sterilized by ethylene oxide (EtO), was previously cleared in K193429. It features three subcomponents: a cup manufactured from X3 UHMWE, a radiopaque wire manufactured from Rex 734 Stainless Steel (Orthinox), and cement spacers manufactured from TS2270 PMMA.
The subject Exeter X3-GP RimFit Cup and Exeter X3-EtO RimFit Cup are compatible for use with Stryker Orthopaedics V40 femoral heads, universal taper femoral heads, and C-Taper femoral heads as previously cleared in K111848.
The purpose of the submission is to modify the labeling to remove a contraindication for obesity.
Indications for Use
There are no changes to the previously cleared indications for use. The indications for use for the subject Exeter X3 RimFit Cups are as follows.
The indications for use for total hip arthroplasty include:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other . procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results.
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- Where bone stock is of poor quality or inadequate for other reconstructive techniques, . such as cementless fixation, as indicated by deficiencies of the acetabulum.
The Exeter X3 RimFit Cup is intended for cemented use only.
Summary of Technological Characteristics
There have been no changes to the technological characteristics of the subject devices as a result of the revision to the labeling. The subject Exeter X3 RimFit Cups have identical design and are manufactured from the same materials as the predicate Exeter X3 RimFit Cups.
Non-Clinical Testing
Based on the definitions for contraindications and warnings from the FDA Device Labeling Guidance #G91-1, obesity should not be considered a contraindication to total hip arthroplasty, but rather a warning that should be adequately assessed by the surgeon and clearly communicated to the patient. The current subject device labeling already has a warning regarding obesity. Performance testing was not required in support of this labeling modification.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence.
Conclusion
The subject Exeter X3 RimFit Cups are substantially equivalent to the predicate Exeter X3 RimFit Cups identified in this premarket notification. Device comparison demonstrated that the subject Exeter X3 RimFit Cups devices are identical in design, indications for use, materials, operational principles, and performance characteristics to the predicate Exeter X3 RimFit Cups. The proposed labeling modifications do not affect the safety or effectiveness of the subject devices.