(90 days)
No
The 510(k) summary describes a hip prosthesis, a mechanical implant. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are standard mechanical and biological tests for implants.
Yes
The device, a hip prosthesis, is designed to treat severely painful and/or disabled joints, avascular necrosis, and traumatic fractures, indicating its use in restoring function and alleviating symptoms.
No
Explanation: The provided text describes the AMIStem-H hip prosthesis, which is a surgical implant designed for hip replacement surgery. It is a therapeutic device, not a diagnostic one. Diagnostic devices are used to identify diseases or conditions.
No
The device description clearly states that the device is comprised of physical implants (femoral stems) made of materials, and the performance studies involve physical testing of these implants. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement, addressing conditions like arthritis, necrosis, and fractures. This is a therapeutic device implanted in the body.
- Device Description: The description details femoral stems, modular femoral heads, and acetabular components, which are physical components of a hip prosthesis.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty for primary or revision surgery. The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, KWY, LZY, LPH
Device Description
The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants are line extensions to the Medacta Total Hip Prosthesis system family AMIStem H, Quadra S and Quadra H femoral stems (K093944), AMIStem C & Quadra C SN (K103189), AMIStem and Quadra - Line Extension (K121011), and AMIStem-H Proximal Coating (K161635).
The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants subject of this submission are comprised of the following products:
- AMIStem-H Proximal Coating STD, Stem sizes 00 and 0;
- AMIStem-H Proximal Coating LAT, Stem size 0;
- AMIStem-P STD, Stem sizes 00 – 9;
- AMIStem-P LAT, Stem sizes 0 - 8;
- AMIStem-P Collared STD, Stem sizes 00 – 9; and
- AMIStem-P Collared LAT, Stem sizes 0 - 8.
The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants are part of the brand, Medacta Total Hip Prosthesis system for total and partial hip arthroplasty. The Medacta Total Hip Prosthesis system family consists of femoral stems, modular femoral heads, and acetabular components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip Femoral
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 Studies:
- Performance Tests:
- range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants - Joint Replacement 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 Partial And Total Hip Joint Prostheses - Part 4: Determination Of Endurance Properties And Performance Of Stemmed Femoral Components [Including AMENDMENT 1 (2016)];
- fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants For Surgery - Partial And Total Hip Joint Prostheses - Part 6: Determination Of Endurance Properties Of Head And Neck Region Of Stemmed Femoral Components; and
- pull off force testing: ASTM F2009-00 (Reapproved 2011) Standard Test Method For Determining The Axial Disassembly Force Of Taper Connections Of Modular Prostheses.
- Pyrogenicity:
- Bacterial Endotoxin Test (LAL test) was conducted and met the endotoxin limit of
§ 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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized caduceus. To the right of it is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Medacta International SA % Elizabeth Rose Manager, Regulatory Affairs Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
March 14. 2018
Re: K173794
Trade/Device Name: AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared 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, MEH, KWY, LZY, LPH Dated: December 13, 2017 Received: December 14, 2017
Dear Elizabeth Rose:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared
Indications for Use (Describe)
The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty for primary or revision surgery. The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
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.
| 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)
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
3.0 510(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 Affairs Manager, Medacta International SA Date Prepared: December 13, 2017 Date Revised: March 9, 2018
II. Device
| Device Proprietary Name: | AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared |
|---|---|
| Common or Usual Name: | Femoral Stems |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis |
| Primary Product Code: | LZO, MEH, KWY, LZY, LPH |
| Regulation Number: | 21 CFR 888.3353, 21 CFR 888.3390, 21 CFR 888.3360, 21 CFR 888.3358 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
- Medacta Total Hip Prosthesis AMIStem H, Quadra S and Quadra H femoral stems, ● K093944, Medacta International SA
- AMIStem and Quadra - Line Extension, K121011, Medacta International SA
- AMIStem-H Proximal Coating, K161635, Medacta International SA
IV. Device Description
The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants are line extensions to the Medacta Total Hip Prosthesis system family AMIStem H, Quadra S and
4
Quadra H femoral stems (K093944), AMIStem C & Quadra C SN (K103189), AMIStem and Quadra - Line Extension (K121011), and AMIStem-H Proximal Coating (K161635).
The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants subject of this submission are comprised of the following products:
- AMIStem-H Proximal Coating STD, Stem sizes 00 and 0; ●
- AMIStem-H Proximal Coating LAT, Stem size 0;
- AMIStem-P STD, Stem sizes 00 9; ●
- AMIStem-P LAT, Stem sizes 0 - 8;
- AMIStem-P Collared STD, Stem sizes 00 9; and ●
- AMIStem-P Collared LAT, Stem sizes 0 - 8.
The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants are part of the brand, Medacta Total Hip Prosthesis system for total and partial hip arthroplasty. The Medacta Total Hip Prosthesis system family consists of femoral stems, modular femoral heads, and acetabular components.
V. Indications for Use
The hip prosthesis AMIStem-H, AMIStem-H collared, AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P collared are designed for cementless use in total or partial hip arthroplasty for primary or revision surgery. The hip prosthesis AMIStem-C is designed for cemented use in total or partial hip arthroplasty in primary or revision surgery.
Hip replacement 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.
5
VI. Comparison of Technological Characteristics
The AMIStem-H Proximal Coating, AMIStem-P, and AMIStem-P Collared implants and the predicate devices share the following characteristics:
- sizes;
- stem lengths;
- CCD angle;
- cementless;
- material of construction; ●
- coatings;
- coating composition of the AMIStem-H Proximal Coating only;
- biocompatibility;
- device usage;
- sterility:
- o shelf life; and
- packaging.
The only technological characteristic difference between the AMIStem-H proximal Coating and the predicate devices is the addition of three new sizes STD 00, 0 and LAT 0.
The only technological characteristic difference between the AMIStem-P and AMIStem-P Collared implants and the predicate devices is the coating composition. The AMIStem-P and AMIStem-P Collared implants have a double coating of Ti and HA in the proximal zone of the shaft and a HA coated distal end.
VII. Performance Data
Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed in support of a substantial equivalence determination:
Non-Clinical Studies
- Performance Tests 0
- о range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants - Joint Replacement 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 о Partial And Total Hip Joint Prostheses - Part 4: Determination Of Endurance Properties And Performance Of Stemmed Femoral Components [Including AMENDMENT 1 (2016)];
- fatigue testing: ISO 7206-6 Second Edition 2013-11-15 Implants For Surgery o - Partial And Total Hip Joint Prostheses - Part 6: Determination Of Endurance Properties Of Head And Neck Region Of Stemmed Femoral Components; and
6
- o pull off force testing: ASTM F2009-00 (Reapproved 2011) Standard Test Method For Determining The Axial Disassembly Force Of Taper Connections Of Modular Prostheses.
- Pyrogenicity
- Bacterial Endotoxin Test (LAL test) was conducted and met the endotoxin o limit of