(327 days)
No
The document describes a traditional medical device (femoral heads for hip replacement) and does not mention any AI or ML components in its description, intended use, or performance studies.
No
The device is a femoral head component used in hip arthroplasty, which is a surgical procedure to replace a hip joint. While it aids in restoring function and alleviating pain, it is a prosthetic implant rather than a device that delivers a therapeutic intervention itself.
No
The device is a femoral head used in hip arthroplasty, which is a treatment (replacement of a joint), not a diagnostic procedure.
No
The device description explicitly states the device is made from cobalt-chromium-molybdenum alloy, indicating it is a physical implant and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided information clearly describes the Zimmer Biomet 12/14 CoCr Femoral Heads and Freedom® Heads as implantable medical devices used in hip arthroplasty (joint replacement surgery). They are physical components intended to be surgically placed within the body to restore function to the hip joint.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
• The Zimmer Biomet 12/14 CoCr Femoral Heads are intended for use in total and hemi arthroplasty* in primary and revision patients. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.
- Hemi-Arthroplasty indication is for use with Bipolar Systems only.
• The Zimmer Biomet 12/14 CoCr Freedom® Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.
Product codes
LPH, OQG, KWY, KWZ
Device Description
The Zimmer Biomet 12/14 CoCr Femoral Head and Freedom® Heads. The heads are made from Freedom® Heads cobalt-chromiummolybdenum alloy (CoCrMo) to ISO 5832-12:2007 and ASTM F1537-11.
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
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:
- Pull Off Testing.
- Accelerated Corrosion Fatigue.
- Head Fatigue.
- Resistance to Wear and Head Retention were considered.
Clinical Tests:
- N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 5, 2019
Zimmer, Inc. % Dean Heit Global Regulatory Affairs Project Manager ZimmerBiomet Waterton Ind Estate Bridgend, CF31 3XA Gb
Re: K183457
Trade/Device Name: Zimmer Biomet 12/14 CoCr Femoral Head and Freedom 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, OQG, KWY, KWZ Dated: October 4, 2019 Received: October 7, 2019
Dear Dean Heit:
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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K183457
Device Name
Zimmer Biomet 12/14 CoCr Femoral Heads and Freedom® Heads
Indications for Use (Describe)
• The Zimmer Biomet 12/14 CoCr Femoral Heads are intended for use in total and hemi arthroplasty* in primary and revision patients. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.
- Hemi-Arthroplasty indication is for use with Bipolar Systems only.
• The Zimmer Biomet 12/14 CoCr Freedom® Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.
| 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
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Zimmer Biomet 12/14 CoCr Femoral Head and Freedom® Head 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 August 12, 2005.
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Establishment Registration Number: 1822565 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dean Heit
Global Regulatory Affairs Project Manager
Zimmer Biomet UK.
Waterton Industrial Estate
Bridgend
UK
CF31 3XA
Phone: +44 (0) 1656 678359
Mobile: +44 (0) 7429075094 |
| Date: | 12th December 2018 |
| Subject Device: | Trade Name: Zimmer Biomet 12/14 CoCr Femoral
Head and Freedom® Head |
| | Common Name: Zimmer Biomet 12/14 CoCr Femoral
Head and Freedom® Head |
| | Classification Name: Zimmer Biomet 12/14 CoCr
Femoral Head. |
| | LPH- prosthesis, hip, semi-constrained,
metal/polymer, porous uncemented (21 CFR
888.3358) |
| | OQG - hip prosthesis, semi-constrained, cemented,
metal/polymer, + additive, porous, uncemented (21
CFR 888.3358) |
| | KWY - Hip joint femoral (hemi-hip)
metal/polymer cemented or uncemented prosthesis
(21 CFR 888.3390) |
| | Classification Name: Zimmer Biomet 12/14 CoCr
Freedom® Head. |
4
| • KWZ - Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310) | ||
|---|---|---|
| Primary Predicate Device(s): | K953337 – | Beta Hip Prosthesis |
| Zimmer Inc. | ||
| K142882 | G7 Freedom® And Offset Liners, | |
| Freedom® Head, Size 32. | ||
| Biomet Inc. | ||
| Additional Predicates: | K121874 – | G7 Acetabular System. |
| Biomet Manufacturing Corp. | ||
| Purpose and Device Description: | This traditional 510(k) premarket notification is being |
submitted to obtain clearance for the Zimmer Biomet 12/14 CoCr Femoral Head and Freedom® Heads. The heads are made from Freedom® Heads cobalt-chromiummolybdenum alloy (CoCrMo) to ISO 5832-12:2007 and ASTM F1537-11.
Intended Use and Indications for Use:
The Zimmer Biomet 12/14 CoCr Femoral Heads are intended for use in total and hemi arthroplasty* in primary and revision patients. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.
- Hemi-Arthroplasty indication is for use with Bipolar Systems only.
The Zimmer Biomet 12/14 CoCr Freedom® Heads are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Refer to the acetabular system and femoral stem package inserts for the full description of indications for the construct.
5
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Equivalent to predicate(s).
- Indications for Use: Identical to predicate(s). ●
- Materials: Identical to predicate(s).
- Design Features: Both the subject and predicate devices mate with a variety of femoral stems equipped with tapered necks. The variety of head diameters and neck configurations is equivalent although the subject device is available in a larger range of sizes.
- Sterilization: Identical to predicate. 0
Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: ●
- Pull Off Testing. O
- Accelerated Corrosion Fatigue. O
- Head Fatigue. O
- Resistance to Wear and Head Retention were O considered.
- Clinical Tests: ●
- o N/A
Substantial Equivalence Conclusion
The subject device has the same intended use and equivalent indication for use as the predicate devices. The subject device is made of the identical material using a equivalent manufacturing process as the primary predicate device. In addition, the subject device has equivalent technological characteristics to the predicates and reference device. The performance data and analyses demonstrate that:
- any differences do not raise new questions of o safety and effectiveness; and
- the proposed device is at least as safe and O effective as the legally marketed predicate devices.