(164 days)
No
The summary describes a hip prosthesis, a mechanical implant, and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are standard mechanical and biological tests for implants.
Yes
The device is a hip prosthesis designed to replace painful and/or disabled hip joints, which is a therapeutic function.
No
The device is a hip prosthesis, which is an implant used for hip replacement surgery to treat painful and/or disabled joints, avascular necrosis, or traumatic fractures. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the device is comprised of physical implants (femoral stems) and is part of a system including other physical components like femoral heads and acetabular components. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a hip prosthesis designed for surgical implantation in the human body to replace a damaged hip joint. This is a therapeutic and structural device, not a diagnostic one.
- Device Description: The description details the components of the hip prosthesis (femoral stems, heads, acetabular components) which are all physical implants.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a person's health status, disease, or condition.
- Performance Studies: The performance studies listed are related to the mechanical properties and safety of the implant (range of motion, fatigue testing, pull-off force, pyrogenicity), not diagnostic accuracy or performance.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The hip prosthesis QUADRA-P is designed for cementless use in total or partial hip arthroplasty; for 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, internal fixation, 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 Quadra-P implants are line extensions to Medacta's Total Hip Prosthesis – AMIStem-H, Quadra-S, and Quadra-H Femoral Stems (K093944); AMIStem and Quadra - Line Extension (K121011); AMIStem-P, AMIStem-P Collared, and AMIStem-H Proximal Coating Femoral Stems (K173794); Quadra-H and Quadra-R Femoral Stems (K082792); and AMIStem-H Proximal Coating (K161635).
The Quadra-P implants subject of this submission are comprised of the following products:
- . Quadra-P STD. Stem sizes 0 - 10;
- Quadra-P LAT, Stem sizes 0 - 10.
The Quadra-P implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads, and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).
The Quadra-P implants can be combined with the CoCr Ball Heads (K072857 and K080885), Endo Head (K111145), MectaCer Biolox Option Heads (K131518), or with the 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
- range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants Joint o Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants;
- fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants for Surgery Partial O 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 O 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 о Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses.
- Pvrogenicity .
- 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; and
- the subject devices are not labeled as non-pyrogenic or pyrogen free. O
Clinical Studies:
- No clinical studies were conducted. ●
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.
K093944, K121011, K161635, K143453, K083116, K092265, K103352, K103721, K132879, K171966, K091967, K072857, K080885, K111145, K131518, K073337, K112115
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 contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
October 22, 2018
Re: K181254 Trade/Device Name: Ouadra P 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: September 20, 2018 Received: September 21, 2018
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 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
Daniel S. Ramsey -S 2018.10.22 13:57:19 -04'00'
For 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 Quadra P
Indications for Use (Describe)
The hip prosthesis QUADRA-P is designed for cementless use in total or partial hip arthroplasty; for 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, internal fixation, 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
2.0 510(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: May 08, 2018
II. Device
| Device Proprietary Name: | Quadra-P |
|---|---|
| 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:
- o AMIStem-P. AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems, K173794. Medacta International SA
- Quadra-H and Quadra-R Femoral Stems, K082792, Medacta International SA
IV. Device Description
The Quadra-P implants are line extensions to Medacta's Total Hip Prosthesis – AMIStem-H, Quadra-S, and Quadra-H Femoral Stems (K093944); AMIStem and Quadra - Line Extension (K121011); AMIStem-P, AMIStem-P Collared, and AMIStem-H Proximal Coating Femoral Stems (K173794); Quadra-H and Quadra-R Femoral Stems (K082792); and AMIStem-H Proximal Coating (K161635).
The Quadra-P implants subject of this submission are comprised of the following products:
- . Quadra-P STD. Stem sizes 0 - 10;
4
- Quadra-P LAT, Stem sizes 0 - 10.
The Quadra-P implants are part of the Medacta Total Hip Prosthesis system. The Medacta Total Hip Prosthesis system consists of femoral stems, modular femoral heads, and acetabular components. The acetabular components consist of metal cups and liners made of ultra-high molecular weight polyethylene (UHMWPE) or Highcross highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE). Acetabular components include the Mpact DM (K143453), VersafitCup (K083116 and K092265), VersafitCup CC Trio (K103352), Mpact (K103721 and K132879), Mpact 3D Metal (K171966), and Medacta Bipolar Head (K091967).
The Quadra-P implants can be combined with the CoCr Ball Heads (K072857 and K080885), Endo Head (K111145), MectaCer Biolox Option Heads (K131518), or with the MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).
V. Indications for Use
The hip prosthesis QUADRA-P is designed for cementless use in total or partial hip arthroplasty; for 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.
Comparison of Technological Characteristics VI.
The Quadra-P implants and the predicate devices share the following characteristics:
- sizes; ●
- stem lengths; ●
- CCD angle; ●
- cementless;
- material of construction; ●
- coatings;
- coating composition;
- biocompatibility;
- device usage;
- sterility;
- shelf life; and ●
- packaging. .
5
Quadra-P implants have the same coating composition as the AMIStem-P and AMIStem-P Collared implants: a double coating of Ti and HA in the proximal zone of the shaft and a HA coated distal end. Quadra-P implants have the same design as the Quadra-H implants, with the exception of the head centers distribution of the stem; which is the same as the AMIStem-P and AMIStem-P Collared implants. This also includes a geometric progression of both vertical and lateral offset with the size increase, to better approximate the natural hip anatomy.
Performance Data VII.
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
- range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants Joint o Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants;
- fatigue testing: ISO 7206-4 Third Edition 2010-06-15 Implants for Surgery Partial O 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 O 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 о Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses.
- Pvrogenicity .
- 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; and
- the subject devices are not labeled as non-pyrogenic or pyrogen free. O
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
Based on the above information, the Quadra-P 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 Quadra-P implants are as safe and
6
Quadra-P Traditional 510(k)
effective as the predicate devices, AMIStem-P, AMIStem-P Collared and AMIStem-H Proximal Coating Femoral Stems (K173794) and Quadra-H and Quadra-R Femoral Stems (K082792).
---------------------------------This space intentionally left blank--------------------------------------------------------