(412 days)
None
No
The 510(k) summary describes a physical medical device (an acetabular cup) and its material properties and performance testing. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is an acetabular cup prosthesis used in total hip arthroplasty to rehabilitate damaged hips, which is a therapeutic purpose.
No
The device description clearly states that the ZCA is an acetabular cup prosthesis, which is an implant used in total hip arthroplasty for treatment of joint disease, not for diagnosis.
No
The device description clearly states it is an "acetabular cup prosthesis" manufactured from "Ultra-High Molecular-Weight Polyethylene (UHMWPE)", indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes an acetabular cup prosthesis, which is an implantable device used in hip replacement surgery. It is a physical component inserted into the body to replace a damaged joint.
- Intended Use: The intended use clearly states it's for "rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDID)" through surgical implantation. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The information provided consistently points to a surgical implant, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The acetabular cup is indicated for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDID) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Product codes
JDI
Device Description
ZCA is an acetabular cup prosthesis intended for use in total hip arthroplasty. It is manufactured from conventional Ultra-High Molecular-Weight Polyethylene (UHMWPE).
The current submission is a retrospective 510(k) for devices that are currently marketed in the U.S. Through a review of the changes to the device system based on the current FDA Guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device" (October 25, 2017), Zimmer Inc. has decided to submit a 510(k) for the cumulative changes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hips
Indicated Patient Age Range
skeletally mature individuals
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)
Non-Clinical Tests:
- Performance Evaluation Performance testing was completed on the line extension to determine equivalence to legally marketed devices.
- Shelf Life Accelerated and real time aging testing conducted shows the sterile devices included in this submission have a shelf life of eight vears.
- Compatibility Functional Relationship Analysis, wear performance, range of motion, and lever-out pull-through strength evaluation conducted shows the implants in this submission are compatible with femoral heads.
Clinical Tests: - Clinical test data is not provided for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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July 16, 2020
Zimmer. Inc. Caleb Barylski Specialist, Regulatory Affairs 1800 W. Center Street Warsaw, Indiana 46580
Re: K191449
Trade/Device Name: ZCA All-Poly Acetabular Cups Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI Dated: July 15, 2020 Received: July 16, 2020
Dear Caleb Barylski:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
FOR Vesa Vuniqi 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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Indications for Use
510(k) Number (if known) K191449
Device Name ZCA All-Poly Acetabular Cups
Indications for Use (Describe)
The acetabular cup is indicated for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDID) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
| 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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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ZCA All-Poly Acetabular Cups 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s,' issued on September 13, 2019.
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Establishment Registration Number: 1822565 | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------------|
| Contact Person: | Caleb Barylski
Regulatory Affairs Specialist
Telephone: (574-371-0250)
Email: Caleb.Barylski@zimmerbiomet.com | | |
| Date: | July 14, 2020 | | |
| Subject Device: | Trade Name: ZCA All-Poly Acetabular Cups
Common Name: Hip Prosthesis | | |
| | Classification Name:
• JDI– prosthesis, hip, semi-constrained, metal/polymer, cemented (21 CFR 888.3350) | | |
| Predicate Device(s): | K901240 | NON-METAL
BACKED
ACETABULAR
CUP FOR
CEMENTED | MEDTEK
(purchased by
Zimmer, Inc.) |
| | K030153 | ZCA All-Poly
Acetabular Cup,
Snap-In, Model
8005-946/958-32 | Zimmer, Inc. |
| Purpose and Device
Description: | ZCA is an acetabular cup prosthesis intended for use in
total hip arthroplasty. It is manufactured from
conventional Ultra-High Molecular-Weight Polyethylene
(UHMWPE).
The current submission is a retrospective 510(k) for devices
that are currently marketed in the U.S. Through a review of
the changes to the device system based on the current FDA
Guidance document "Deciding When to Submit a 510(k) for | | |
4
a Change to an Existing Device" (October 25, 2017), Zimmer Inc. has decided to submit a 510(k) for the cumulative changes.
Intended Use and Indications for Use:
The acetabular cup is indicated for cemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to predicates ●
- Indications for Use: Similar to predicates ●
- Materials: Substantially equivalent to predicates ●
- . Design Features: Substantially equivalent to predicates
- . Sterilization: Identical to predicates
Summary of Performance Data (Nonclinical and/or Clinical)
● Non-Clinical Tests:
- Performance Evaluation Performance testing O was completed on the line extension to determine equivalence to legally marketed devices.
- Shelf Life Accelerated and real time aging O testing conducted shows the sterile devices included in this submission have a shelf life of eight vears.
- Compatibility Functional Relationship O Analysis, wear performance, range of motion, and lever-out pull-through strength evaluation conducted shows the implants in this submission are compatible with femoral heads.
- 0 Clinical Tests:
- Clinical test data is not provided for the subject o device.
Substantial Equivalence Conclusion
The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform
5
in a substantially equivalent manner to the legally marketed predicate devices.