(530 days)
The implaFit® hip stems are indicated for use in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis:
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
- Revision of previously failed total hip arthroplasty.
The implaFit® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended for the following indications:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
The implaFit® hip stems cementless are intented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation.
The implaFit® hip stems are femoral stems for total or hemi hip arthroplasty. The implaFit® hip stems include cementless and cemented configurations (i.e., the implaFit® hip stems cementless and the implaFit® hip stems cemented).
The implaFit® hip stems cementless are monoblock, collarless tapered straight stems made from titanium alloy with a partial coating of commercially pure titanium (cpTi). They are fixed by press-fitting.
The implaFit® hip stems cemented are monoblock, collared, tapered straight stems made from cobalt chromium (CoCrMo). They are fixed using cement.
The provided text describes a 510(k) premarket notification for a medical device, the implaFit® hip stems, and primarily focuses on demonstrating its substantial equivalence to legally marketed predicate devices. This type of submission relies heavily on non-clinical performance testing rather than clinical study data involving AI.
Therefore, the information required to answer the prompt regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm study (which would involve concepts like sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training sets) is not present in the provided document.
The document describes performance testing for the physical device components (e.g., fatigue testing, impingement testing, coating testing). These tests have "predetermined acceptance criteria" related to the physical properties and performance of the hip stems, and the document states that "All performance testing conducted for the implaFit® hip systems met the predetermined acceptance criteria or were otherwise considered acceptable." However, this is not an AI-driven study.
In summary, this document does not contain the information needed to fill out the table or answer the questions related to an AI/algorithm study as requested.
If the request were about the acceptance criteria and study for a physical medical device, a different table and set of questions would be appropriate.
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August 17, 2022
implantcast, GmbH % Dave McGurl Vice President, Regulatory Affairs - Orthopedics MCRA, LLC. 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K210678
Trade/Device Name: implaFit® hip stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, KWY, JDI Dated: July 20, 2022 Received: July 21, 2022
Dear Dave McGurl:
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 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 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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Indications for Use
510(k) Number (if known)
K210678
Device Name implaFit® hip stems
Indications for Use (Describe)
The implaFit® hip stems are indicated for use in cases of:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
-
Rheumatoid arthritis:
-
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
-
Revision of previously failed total hip arthroplasty.
The implaFit® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended for the following indications:
-
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
Rheumatoid arthritis
-
Correction of functional deformity
-
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
The implaFit® hip stems cementless are intented, press-fit fixation. The implaFit® hip stems cemented are intended for cemented fixation.
| 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
| Manufacturer: | implantcast GmbHLueneburger Schanze 2621614 BuxtehudeGermany |
|---|---|
| Contact: | Ms. Juliane HöppnerPhone: +49 4161 744-135Fax: +49 4161 744-200j.hoeppner@implantcast.de |
| Prepared By: | Mr. Dave McGurlMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: 202.552.5797dmcgurl@mcra.com |
| Date Prepared: | August 15, 2022 |
| Device Trade Name: | implaFit® hip stems |
| Device Class andCommon Name: | Class II, Total Hip Replacement |
| Classification: | 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis.21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. |
| Product Codes: | LZO, KWY, JDI |
| Indications for Use: | The indications for use for the proposed implaFit® hip stems are as follows:The implaFit® hip stems are indicated for use in cases of:- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; |
| - Treatment of non-union, femoral neck fracture,and trochanteric fractures of the proximal femurwith head involvement that are unmanageable byother techniques; and- Revision of previously failed total hiparthroplasty. | |
| The implaFit® hip stems, when used in conjunction withthe ic-Bipolar Heads, are intended for the followingindications: | |
| - Non-inflammatory degenerative joint diseaseincluding osteoarthritis and avascular necrosis- Rheumatoid arthritis- Correction of functional deformity- Treatment of non-union, femoral neck fracture andtrochanteric fractures of the proximal femur withhead involvement, unmanageable using othertechniques. | |
| The implaFit® hip stems cementless are intended foruncemented, press-fit fixation. The implaFit® hip stemscemented are intended for cemented fixation. | |
| Device Description: | The purpose of this Traditional 510(k) is introduce intointerstate commerce in the United States the implaFit® hipstems. The implaFit® hip stems are femoral stems for total orhemi hip arthroplasty. The implaFit® hip stems includecementless and cemented configurations (i.e., the implaFit®hip stems cementless and the implaFit® hip stems cemented). |
| The implaFit® hip stems cementless are monoblock,collarless tapered straight stems made from titanium alloywith a partial coating of commercially pure titanium (cpTi).They are fixed by press-fitting. | |
| The implaFit® hip stems cemented are monoblock, collared,tapered straight stems made from cobalt chromium(CoCrMo). They are fixed using cement. | |
| Predicate Devices: | Primary Predicate:EcoFit® Hip System (K163577)Reference Devices:- EcoFit® Hip System (K180263, K191569)- DePuy Orthopaedics, Inc. Summit DuoFix Hip(K193398)- Summit Cemented Hip Prosthesis (K013352) |
| SubstantialEquivalence: | The implaFit® hip stems cementless are similar tocomponents previously cleared with the EcoFit® Hip System |
- Rheumatoid arthritis; -
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(K191569). Both are cementless femoral hip stems that are monoblock, collarless, tapered (12/14), and made from titanium alloy. In addition, both have a commercially pure titanium (cpTi) coating on the proximal end side of the stem, starting at the upper shoulder.
There are some differences in stem material, geometry, and dimensions implaFit® hip stems as compared to the EcoFit® Hip System predicate. These differences include the material, cross-sectional geometry, head/neck angle, stem length (lower shoulder to tip), neck length, and offset length.
The implaFit® hip stems are substantially equivalent to the hip stems of the legally marketed predicate device systems, Hip System, the implantcast the DePuy Orthopaedics, Inc. Summit Cemented Hip Prosthesis, and the DePuy Orthopaedics, Inc. Summit DuoFix Hip with respect to intended use and design.
- Performance Testing: All necessary testing has been performed for the "worst-case" components of the implaFit® hip stems to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. All testing was performed on test units representative of or worst-case compared to the finished device. The following evaluations were conducted to characterize the devices:
- . Fatigue Testing (ISO 7206-4 and ISO 7206-6)
- Impingement Testing (ASTM F2582-14)
- . Taper Disassembly Testing (ASTM F1820)
- Range of Motion (ROM) Evaluation (ISO 21535)
- . Coating Testing (ASTM F1147, F1044, F1978, F1854, F1160)
- Wear / Corrosion Evaluation
Conclusions: The implaFit® hip stems subject to this submission possess the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the implaFit® hip systems met the predetermined acceptance criteria or or were otherwise considered acceptable. As such, the implaFit® hip stems components are substantially equivalent to the predicate devices for the intended use.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.