(29 days)
No
The device description and performance studies focus on the mechanical properties and design of a hip implant component, with no mention of AI or ML.
Yes
The device is described as an acetabular cup (a component of a total hip system) used to treat mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is a prosthetic hip component (Vario-Cup System) intended for implantation to treat mobility-limiting diseases, fractures, or defects of the hip joint. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of UHMWPE and CoCrMo, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for treating mobility-limiting diseases, fractures, and defects of the hip joint and proximal femur through surgical implantation. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implant (acetabular cup) designed to articulate within the hip joint. This is consistent with a surgical implant, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
- Anatomical Site: The device is intended for the hip joint and proximal femur, which are anatomical locations within the body, not samples taken from the body for in vitro analysis.
In summary, the device is a surgical implant used to treat conditions of the hip joint, which falls under the category of a medical device but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.
Femoral neck fractures.
Correction of functional deformities.
Product codes (comma separated list FDA assigned to the subject device)
KWY
Device Description
The Vario-Cup System consists of an UHMWPE component encased in an ultra-smooth polished EndoDur (CoCrMo) outer metal casing, for articulation in the bony acetabulum. It is to be used in conjunction with femoral components of the LINK Total Hip Systems. The 22 mm inner diameter Vario-Cup Prostheses are available in outer diameters ranging from 39-43 mm in 1 mm increments. Vario-Cups are self-centering which provides for a functional view of their position in post-op X-rays. An anti-luxation feature resists dislocation: an UHMWPE Safety Ring is placed in a groove at the entrance of the polyethylene insert after assembly of Vario-Cup and femoral components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint or proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Performance and Conclusions:
The following performance testing and analysis were performed to demonstrate that the 22 mm Vario-Cup System performs as intended and is substantially equivalent to the identified predicate devices:
- Material Characterization
- Disassembly Analysis
- -Range of Motion Analysis
- Material Wear Analysis
The results of non-clinical performance testing and analysis demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
There was no clinical performance testing required for this device.
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
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
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July 20, 2022
Waldemar Link GmbH & Co. KG % Mateusz Leszczak Regulatory Affairs Manager LinkBio Corp. 69 King Street Dover, New Jersey 07801
Re: K221794
Trade/Device Name: Vario-Cup System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY Dated: June 21, 2022 Received: June 21, 2022
Dear Mateusz Leszczak:
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.
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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); 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.
Limin Sun, Ph.D. 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) K221794
Device Name Vario-Cup System
Indications for Use (Describe)
Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.
Femoral neck fractures.
Correction of functional deformities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| 510(k) Submitter: | Waldemar Link GmbH & CO. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration #:3004371426 (Oststraße 4-10) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Pia Müller (Regulatory Affairs)
Oststraße 4-10
Norderstedt, GERMANY 22844
Phone: +49-40 53995-841
Fax: +49-40 53995-174
E-Mail: P.Mueller@linkhh.de |
| Date Prepared: | July 18, 2022 |
| Trade Name: | Vario-Cup System |
| Common Name: | Hemi-Hip Prosthesis |
| Classification Name: | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer,
Cemented or Uncemented; 21 CFR §888.3390, product
code KWY |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | Waldemar Link GmbH & Co. KG. ENDOPROSTHESIS
SYSTEM, VARIO-HEAD. K781735 [Primary Predicate]
AESCULAP, INC. AESCULAP BIPOLAR ACETABULAR
CUP. K060707 [Additional Predicate]
Waldemar Link GmbH & Co. KG. LINK ®
MEGASYSTEM-C®. K151008 [Reference Device] |
| Device Description: | The Vario-Cup System consists of an UHMWPE
component encased in an ultra-smooth polished
EndoDur (CoCrMo) outer metal casing, for articulation in
the bony acetabulum. It is to be used in conjunction with
femoral components of the LINK Total Hip Systems. The
22 mm inner diameter Vario-Cup Prostheses are
available in outer diameters ranging from 39-43 mm in
1 mm increments. Vario-Cups are self-centering which
provides for a functional view of their position in post-op
X-rays. An anti-luxation feature resists dislocation: an
UHMWPE Safety Ring is placed in a groove at the |
4
entrance of the polyethylene insert after assembly of Vario-Cup and femoral components.
- Indications for Use: Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.
Femoral neck fractures.
Correction of functional deformities.
Comparison to Predicate Device: The additional 22mm Vario-Cup devices have the same intended use as the predicate devices and use materials identical to those used in the primary predicate ENDOPROSTHESIS SYSTEM, VARIO-HEAD K781735. The design of the subject and primary predicate devices has the same technological characteristics except: the subject device sizes are used with 22 mm heads and incorporate the anti-luxation safety ring, a design feature found in the 28 mm and 32 mm predicate devices but not the 24 mm predicate device variants.
The subject 22mm Vario-Cup devices are also similar to the additional predicate AESCULAP BIPOLAR ACETABULAR CUP K060707, which is also a dual mobility system and consists of a highly polished Cobalt Chrome alloy (CoCrMo) shell and a UHMWPE insert offered to fit either 22mm or 28mm heads. Both the Vario-Cup and AESCULAP BIPOLAR ACETABULAR systems are self-centering, and both feature a polyethylene locking ring.
The Vario-Cup Indications for Use are more specific than the original Primary Predicate K781735, and are consistent with similar contemporary predicate devices i.e. K060707.
The performance testing and analysis is sufficient to demonstrate that the subject and predicate devices are substantially equivalent with regard to design. Any difference between the subject and predicate device does not change the intended use or fundamental scientific technology.
Performance Data: Non-Clinical Performance and Conclusions:
The following performance testing and analysis were performed to demonstrate that the 22 mm Vario-Cup System performs as intended and is substantially equivalent to the identified predicate devices:
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- Material Characterization
- Disassembly Analysis -
- -Range of Motion Analysis
- Material Wear Analysis
The results of non-clinical performance testing and analysis demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
There was no clinical performance testing required for this device.
Conclusion:
The subject device 22 mm Vario-Cup System is substantially equivalent to the predicate devices identified in this premarket notification.