(642 days)
Not Found
No
The document describes a mechanical hip implant component and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is a CoCr femoral head used in total hip arthroplasty to treat conditions like avascular necrosis, osteoarthritis, and rheumatoid arthritis, which are therapeutic indications for restoring function and reducing pain.
No
This medical device is a modular head component for total hip arthroplasty, which is an implant used for joint replacement, not for diagnosing conditions.
No
The device description clearly states it is a "modular head component for articulation in total hip arthroplasty" made from "Protasul®-20 (CoCrMo alloy)". This describes a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the treatment of joint diseases and revision of hip arthroplasty. This is a surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a modular head component for total hip arthroplasty, designed to be implanted in the body. IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic procedures.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Noninflammatory degenerative (oint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory (out disease (IJD), e.g., rheumatoid arthritis.
- Failed previous surgery where pain, deformity, or dysfunction persists.
- Revision of previously failed hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
LPH, JDI
Device Description
The Subject CoCr Heads are intended to be used as a modular head component for articulation in total hip arthroplasty. A system consisting of a femoral stem, a ball head and a cup or a shell with an insert is used for replacement of the proximal femur in total hip arthroplasty. The articulation is comprised of a modular femoral head and a corresponding cup or acetabular insert. CoCr Heads are to be used in combination with polyethylene cups or inserts. It is also possible to use CoCr Heads in revision cases (unless subsequent to a broken ceramic component) where the stem remains in place.
The Subject CoCr Heads have a head diameter of 38 mm and are provided with 5 different neck lengths (from -8 to +8) to allow an individual adaptation of leg length and offset. A 12/14 taper, incorporated in the design of the head, interlocks with the femoral stem. The CoCr Heads are made from Protasul®-20 (CoCrMo alloy).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip joint
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)
Non-Clinical Performance and Conclusions: Results from engineering analyses demonstrate that the subject CoCr Heads for which the expansion of product compatibility is proposed remains substantially equivalent to the predicate devices cleared under K993259. This conclusion has been supported by rationales for wear justification, material equivalence (ISO 5834-1, ISO 5834-2, ASTM F648-10, ASTM F2565-06, ASTM F2759-11) and Range of Motion according to ISO 21535. The interactions of Zimmer Hip Joint Replacement implants with static and time varying magnetic fields during Magnetic Resonance Imaging procedures have been evaluated and the subject CoCr Heads have been determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. Data and scientific rationalizations to quantify the RF-induced heating, static magnetic field interactions, and image artifact generation of the Zimmer Hip Joint Replacement implants in the 1.5 Tesla (T) and 3.0 T MRI clinically relevant environments have been generated.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed 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.
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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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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 logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 10, 2023
Zimmer GmbH Nuno Pereira Regulatory Affairs Specialist Sulzerallee 8 Winterthur, Zurich 8404 Switzerland
Re: K211047
Trade/Device Name: CoCr Head Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI Dated: December 9, 2022 Received: December 12, 2022
Dear Nuno Pereira:
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
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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 medical devices and radiation-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 Su
Limin Sun, Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211047
Device Name CoCr Head
Indications for Use (Describe)
- · Noninflammatory degenerative (oint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory (out disease (IJD), e.g., rheumatoid arthritis.
- · Failed previous surgery where pain, deformity, or dysfunction persists.
- · Revision of previously failed hip arthroplasty.
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
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Nuno Pereira
Regulatory Affairs Specialist
Telephone: +41 76 736 51 91
Fax: +41 52 244 86 58 |
| Date: | December 21, 2022 |
| Trade Name: | CoCr Head |
| Common Name | Hip Prosthesis |
| Classification Product Code: | LPH, JDI |
| Device Classification Name: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous
Uncemented |
| | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Regulation Number /
Description: | 21 CFR § 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, LPH |
| | 21 CFR § 888.3350 - Hip joint metal/polymer semi-constrained cemented prosthesis, JDI |
| | |
| Predicate Device: | CoCr Head, manufactured by Zimmer GmbH, K993259, cleared
March 10th, 2000 |
| Device Description: | The Subject CoCr Heads are intended to be used as a modular head component for articulation in total hip arthroplasty. A system consisting of a femoral stem, a ball head and a cup or a shell with an insert is used for replacement of the proximal femur in total hip arthroplasty. The articulation is comprised of a modular femoral head and a corresponding cup or acetabular insert. CoCr Heads are to be used in combination with polyethylene cups or inserts. It is also possible to use CoCr Heads in revision cases (unless subsequent to a broken ceramic component) where the stem remains in place. |
| | The Subject CoCr Heads have a head diameter of 38 mm and are provided with 5 different neck lengths (from -8 to +8) to allow an individual adaptation of leg length and offset. A 12/14 taper, incorporated in the design of the head, interlocks with the femoral stem. The CoCr Heads are made from Protasul®-20 (CoCrMo alloy). |
| Indications For Use: | Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.Failed previous surgery where pain, deformity, or dysfunction persists.Revision of previously failed hip arthroplasty. |
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Device: device remain identical to the predicate device. The subject devices have the same intended use and are substantially equivalent to the legally marketed predicate devices. Minor modifications have been implemented since the last clearance. With this submission, it is proposed to: . establish compatibility of the subject CoCr Heads with the legally marketed Epsilon Durasul Constrained Acetabular Liners. The proposed compatibility extension does not alter the fundamental scientific technology shared by both the subject device and predicate device. ● implement MR Conditional labeling for the CoCr Heads. The addition of the MR Conditional labeling does not alter the Indications for Use of the subject devices. Performance Data Non-Clinical Performance and Conclusions: (Nonclinical and/or Clinical): Results from engineering analyses demonstrate that the subject CoCr Heads for which the expansion of product compatibility is proposed remains substantially equivalent to the predicate devices cleared under K993259. This conclusion has been supported by rationales for wear justification, material equivalence (ISO 5834-1, ISO 5834-2, ASTM F648-10, ASTM F2565-06, ASTM F2759-11) and Range of Motion according to ISO 21535. The interactions of Zimmer Hip Joint Replacement implants with static and time varying magnetic fields during Magnetic Resonance Imaging procedures have been evaluated and the subject CoCr Heads have been determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. Data and scientific rationalizations to quantify the RF-induced heating, static magnetic field interactions, and image artifact generation of the Zimmer Hip Joint Replacement implants in the 1.5 Tesla (T) and 3.0 T MRI clinically relevant environments have been generated. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device. Conclusion: The subject devices have the same intended use and similar indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and are manufactured and sterilized using the same materials and processes as the predicate devices. Except for the modifications described in this submission the subject devices are identical to the predicate devices, and the performance data and analyses demonstrate that: . any differences do not raise new questions of safety and effectiveness as established with performance testing; and the subject devices are at least as safe and effective as the ● legally marketed predicate devices.