(57 days)
No
The 510(k) summary describes a mechanical hip prosthesis and its components. There is no mention of software, algorithms, AI, or ML in the intended use, device description, or performance studies.
Yes
Explanation: The device is a hip prosthesis designed for total or partial hip arthroplasty to alleviate pain and restore function in diseased or damaged hip joints, which serves a therapeutic purpose.
No
The device described is a hip prosthesis, which is an implant used in surgical procedures to replace a damaged hip joint. Its purpose is therapeutic, not diagnostic.
No
The device description clearly indicates that the device is a physical hip prosthesis, including a cemented stem, femoral heads, and acetabular components made of materials like stainless steel and polyethylene. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a hip prosthesis (stem, heads, cups, liners), materials, and sizes. This aligns with a surgical implant.
- Performance Studies: The performance studies focus on mechanical properties (pull-off, range of motion, fatigue testing) and biocompatibility (pyrogenicity), which are relevant for surgical implants. There are no studies related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
Therefore, the AMIS-K Long hip prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The hip prosthesis AMIS-K Long is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Total hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia
- Avascular necrosis of the femoral head
- · Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty.
Partial hip arthroplasty is indicated in the following cases:
· Acute traumatic fracture of the femoral head or neck
- · Non-union of femoral neck fracture
- · Avascular necrosis of the femoral head.
- · Primary pathology involving the femoral head but with a non-deformed acetabulum.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI, MEH, KWY
Device Description
The AMIS-K Long cemented stem is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
The AMIS-K Long is a straight, double-tapered cemented stem whose primary stability is ensured by bone cement.
The AMIS-K Long implants in this submission are comprised of the following size: from #2 to #5 with 2 different stem body size for #2, #3 and #4, 1 different stem body size for #5. Stem length: 200 - 250 - 300 mm (for each size).
The AMIS-K Long implants are part of the Medacta Total Hip Prosthesis system.
The Medacta Total Hip Prosthesis system consists of femoral stemoral heads, and acetabular components.
The AMIS-K Long are cemented stems manufactured from high nitrogen stainless steel (ISO 5832-9) with a mirror polished surface.
The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high polyethylene (HXUHMWE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352, K120531 and K122911), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).
The AMIS-K Long implants can be combined with the CoCr Ball Heads (K072857 and K080885). Endo Head (K111145), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).
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
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 Studies:
- Performance Tests
- Pull-Off: ASTM F2009-00 (Reapproved 2011) Test on CoCr Femoral O Head according to Test Protocol IL 07.09.033, EndoLab Test Report, No .: 167.081021.10.1144, CeramTec AG Test Reports 3129 and 3300.
- range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical O Implants - JointReplacement Implants - Specific Requirements for Hip-Joint Replacement Implants(ISO 21535:2007/Amendment 1:2016);
- fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants For Surgery -O Partial And Total Hip Joint Prostheses - Part 4:
- Determination Of Endurance Properties And Performance Of Stemmed O Femoral Components [Including AMENDMENT 1 (2016)];
- fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants For O Surgery -Partial And Total Hip Joint Prostheses - Part 6: Determination Of Endurance Properties Of Head And Neck Region Of Stemmed Femoral Components;
- Design Validation Protocol and workshop O
- Pyrogenicity ●
- Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination.
- the subject devices are not labeled as non-pyrogenic or pyrogen free. O
Clinical Studies:
- No clinical studies were conducted. .
Key results: The information provided above supports that the Amis-K Long implants are substantially equivalent to the identified predicate devices. Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations. The Amis K Long implants are as safe and effective as the predicate 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.
K192827, K201471, K083558, K100469
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.
Not Found
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: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font. The logo is simple and professional, conveying the agency's authority and mission.
April 12, 2022
Medacta International S.A. % Chris Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K220405
Trade/Device Name: Amis K Long 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, JDI, MEH, KWY Dated: February 10, 2022 Received: February 14, 2022
Dear Chris Lussier:
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
1
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. Acting 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) K 220405
Device Name
Amis K Long
Indications for Use (Describe)
The hip prosthesis AMIS-K Long is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Total hip replacement is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia
- Avascular necrosis of the femoral head
- · Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty.
Partial hip arthroplasty is indicated in the following cases:
· Acute traumatic fracture of the femoral head or neck
- · Non-union of femoral neck fracture
- · Avascular necrosis of the femoral head.
- · Primary pathology involving the femoral head but with a non-deformed acetabulum.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Sr. Director, Quality, Regulatory, and Clinical, Medacta USA Date Prepared: February 10, 2022 Date Revised: April 12, 2022
II. Device
| Device Proprietary Name: | Amis K Long |
|---|---|
| Common or Usual Name: | Femoral Stems |
| Classification Name: | Hip Joint Metal/Ceramic/Polymer Semi-Constrained |
| Cemented Or Nonporous Uncemented Prosthesis | |
| Primary Product Code: | LZO |
| Secondary Product Codes | JDI, MEH, KWY |
| Regulation Number: | 21 CFR 888.3353, 21 CFR 888.3350, 21 CFR 888.3390 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary predicate device:
-
Quadra-P Cemented, K192827, Medacta International SA ●
Additional predicate device: -
M-Vizion K201471, Medacta International SA ●
-
Quadra C, K083558, Medacta International SA
-
Arcos, K100469, Biomet ●
4
IV. Device Description
The AMIS-K Long cemented stem is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
The AMIS-K Long is a straight, double-tapered cemented stem whose primary stability is ensured by bone cement.
The AMIS-K Long implants in this submission are comprised of the following size: from #2 to #5 with 2 different stem body size for #2, #3 and #4, 1 different stem body size for #5. Stem length: 200 - 250 - 300 mm (for each size).
The AMIS-K Long implants are part of the Medacta Total Hip Prosthesis system.
The Medacta Total Hip Prosthesis system consists of femoral stemoral heads, and acetabular components.
The AMIS-K Long are cemented stems manufactured from high nitrogen stainless steel (ISO 5832-9) with a mirror polished surface.
The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE), or Highcross highly crosslinked ultra-high polyethylene (HXUHMWE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352, K120531 and K122911), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).
The AMIS-K Long implants can be combined with the CoCr Ball Heads (K072857 and K080885). Endo Head (K111145), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).
V. Indications for Use
The hip prosthesis AMIS-K Long is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Total hip arthroplasty is indicated in the following cases:
- · Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
- · Avascular necrosis of the femoral head
- · Acute traumatic fracture of the femoral head or neck
- · Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement, or total hip arthroplasty.
Partial hip arthroplasty is indicated in the following cases:
- Acute traumatic fracture of the femoral head or neck ●
- Non-union of femoral neck fracture ●
- Avascular necrosis of the femoral head.
- Primary pathology involving the femoral head but with a non-deformed acetabulum. ●
5
VI. Comparison of Technological Characteristics
The subject Amis K Long implants and the predicate device Quadra-P cemented (K192827) share the following similarities:
- Intended use ●
- Cemented stem ●
- Femoral Stem Trunnion Geometry
- Materials ●
- Surface finish ●
- Same compatible acetabular systems ●
The main differences between the subject Amis K Long implants and the predicate device Quadra-P cemented (K192827) are:
- . Stem design : Charnley-Kerboull stem VS straight, triple tapered with rectangular cross-section (Amis K Long VS Quadra-P cemented respectively)
- CCD (caput-collum-diaphyseal) angle : 130° VS 135°/127° ● (Amis K Long VS Quadra-P cemented respectively)
- Stem length ●
Comparison with additional predicate devices:
Medacta International SA has not made any change to, sterility and shelf life of the subject devices respect to the predicate device and the additional predicate device M-Vizion K201471.
The subject Amis K Long stem is similar in length to other cleared uncemented hip stems, such as Medacta M-Vizion (K201471) and Biomet Arcos Interlocking Distal Stems (K100469).
VII. Performance Data
Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed on worst-case stems in support of a substantial equivalence determination:
Non-Clinical Studies:
- Performance Tests
- Pull-Off: ASTM F2009-00 (Reapproved 2011) Test on CoCr Femoral O Head according to Test Protocol IL 07.09.033, EndoLab Test Report, No .: 167.081021.10.1144, CeramTec AG Test Reports 3129 and 3300.
- range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical O Implants - JointReplacement Implants - Specific Requirements for Hip-Joint Replacement Implants(ISO 21535:2007/Amendment 1:2016);
- fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants For Surgery -O Partial And Total Hip Joint Prostheses - Part 4:
- Determination Of Endurance Properties And Performance Of Stemmed O Femoral Components [Including AMENDMENT 1 (2016)];
- fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants For O Surgery -Partial And Total Hip Joint Prostheses - Part 6: Determination Of Endurance Properties Of Head And Neck Region Of Stemmed Femoral Components;
6
- Design Validation Protocol and workshop O
- Pyrogenicity ●
- Bacterial Endotoxin Test (LAL test) was conducted according to European O Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination.
- the subject devices are not labeled as non-pyrogenic or pyrogen free. O
Clinical Studies:
- No clinical studies were conducted. .
VIII. Conclusion
The information provided above supports that the Amis-K Long implants are substantially equivalent to the identified predicate devices.
Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations. The Amis K Long implants are as safe and effective as the predicate device.