(530 days)
No
The summary describes a mechanical hip implant and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies listed are standard mechanical and material tests for implants.
Yes
The device is a hip stem used in total or hemi hip arthroplasty to treat various joint diseases and fractures, which falls under the definition of a therapeutic device.
No
The device is a hip stem used in arthroplasty, which is a treatment for joint diseases, not a diagnostic tool.
No
The device description clearly states the device is a physical implant (femoral stems for hip arthroplasty) made of titanium alloy or cobalt chromium, with different configurations for cementless or cemented fixation. The performance studies also describe physical testing of these components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The implaFit® hip stems are implants designed to be surgically placed within the human body to replace or repair a damaged hip joint.
- Intended Use: The intended use clearly states the device is for treating conditions like osteoarthritis, rheumatoid arthritis, fractures, and failed hip arthroplasty by being implanted into the proximal femur.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, KWY, JDI
Device Description
The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the implaFit® hip stems. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip Joint / Proximal Femur
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)
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
Key results: All performance testing conducted for the implaFit® hip systems met the predetermined acceptance criteria or or were otherwise considered acceptable.
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.
K180263, K191569, K193398, K013352
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
§ 888.3353 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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.
1
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
2
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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3
510(K) SUMMARY
| Manufacturer: | implantcast GmbH
Lueneburger Schanze 26
21614 Buxtehude
Germany |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ms. Juliane Höppner
Phone: +49 4161 744-135
Fax: +49 4161 744-200
j.hoeppner@implantcast.de |
| Prepared By: | Mr. Dave McGurl
MCRA, LLC
1050 K Street NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5797
dmcgurl@mcra.com |
| Date Prepared: | August 15, 2022 |
| Device Trade Name: | implaFit® hip stems |
| Device Class and
Common Name: | Class II, Total Hip Replacement |
| Classification: | 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
21 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 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 intended for
uncemented, press-fit fixation. The implaFit® hip stems
cemented are intended for cemented fixation. |
| Device Description: | The purpose of this Traditional 510(k) is introduce into
interstate commerce in the United States the implaFit® hip
stems. 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. |
| Predicate Devices: | Primary Predicate:
EcoFit® Hip System (K163577)
Reference Devices:
-
EcoFit® Hip System ([K180263](https://510k.innolitics.com/search/K180263), [K191569](https://510k.innolitics.com/search/K191569)) -
DePuy Orthopaedics, Inc. Summit DuoFix Hip
(K193398)
-
Summit Cemented Hip Prosthesis ([K013352](https://510k.innolitics.com/search/K013352)) |
| Substantial
Equivalence: | The implaFit® hip stems cementless are similar to
components previously cleared with the EcoFit® Hip System |
- Rheumatoid arthritis; -
4
5
(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.