(96 days)
No
The device description and performance studies focus on the mechanical properties and materials of the hip prostheses, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
A hip prosthesis is a therapeutic device designed to alleviate pain, restore joint function, and improve mobility for patients suffering from severe hip joint conditions.
No
This device, a hip prosthesis, is a surgical implant used for hip replacement. It is designed to treat painful and/or disabled joints by replacing damaged bone and cartilage, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states that the device is comprised of physical implants (femoral stems, modular femoral heads, and acetabular components) made of materials like Titanium-Niobium alloy and stainless steel. This indicates it is a hardware medical device, not software-only.
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 the hip prosthesis (stems, heads, cups, liners) and the materials they are made from. This aligns with a medical device intended for implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies described are related to the mechanical properties and safety of the implant (range of motion, fatigue testing, pyrogenicity), not diagnostic accuracy.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is an in vivo (inside the body) implant.
N/A
Intended Use / Indications for Use
The hip prostheses QUADRA-P and QUADRA-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis QUADRA-P cemented 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
LZO, MEH, KWY, LZY, LPH, JDI
Device Description
The Quadra-P implants are line extensions to the currently cleared Quadra-P implants (K181254).
The Quadra-P implants in this submission are comprised of the following products:
- Quadra-P STD (Stem size 00);
- Quadra-P Short Neck (STD Stem sizes 0 - 10 and LAT Stem sizes 0 - 10);
- Quadra-P Collared (STD Stem sizes 00 - 10 and LAT Stem sizes 0 - 10); and
- Quadra-P Cemented (STD Stem sizes 0 - 8 and LAT Stem sizes 0 - 8).
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 Quadra-P, Quadra-P short neck, and Quadra-P Collared are cementless stems manufactured from Titanium-Niobium alloy with a Titanium plasma spray coating (MectaGrip) on the proximal area and HA coating on the shaft. The Quadra-P Cemented stems manufactured from high nitrogen stainless steel.
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, K120521 and K122911), 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), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115). or MectaCer Biolox Option Heads (K131518).
MectaCer Biolox Option Heads (K131518) cannot be combined with Quadra-P cemented stems, but only with the Quadra-P cementless stems.
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
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;
- static fatigue testing: ISO 7206-10:2003 Implants For Surgery -- Partial And Total Hip-Joint Prostheses -- Part 10: Determination Of Resistance To Static Load Of Modular Femoral Heads; 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 according to European 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.
Clinical Studies:
- No clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K192827
Trade/Device Name: Quadra-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, JDI Dated: September 30, 2019 Received: October 2, 2019
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.
January 6, 2020
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 (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 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.
FOR Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K192827
Device Name Quadra-P
Indications for Use (Describe)
The hip prostheses QUADRA-P and QUADRA-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis QUADRA-P cemented 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.
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
Quadra-P Traditional 510(k)
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 and Compliance Director, Medacta International SA Date Prepared: September 30, 2019
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 un-cemented prosthesis | |
| Primary Product Code: | LZO |
| Secondary Product Codes: | MEH, KWY, LZY, LPH, JDI |
| Regulation Number: | 21 CFR 888.3353, 21 CFR 888.3390, 21CFR 888.3360, 21 |
| CFR 888.3358, | |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
Primary predicate device:
-
Quadra-P, K181254, Medacta International SA ●
Secondary predicate device: -
Medacta Total Hip Prosthesis System Quadra C (also referred to as "Quadra C"), K083558, . Medacta International SA
The following devices are referenced: -
AMIStem-H Proximal Coating, K121011, Medacta International SA ●
-
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared, K173794, Medacta . International SA
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K192827 Page 2/4
Quadra-P Traditional 510(k)
IV. Device Description
The Quadra-P implants are line extensions to the currently cleared Quadra-P implants (K181254).
The Quadra-P implants in this submission are comprised of the following products:
- Quadra-P STD (Stem size 00); .
- Quadra-P Short Neck (STD Stem sizes 0 10 and LAT Stem sizes 0 10); ●
- . Quadra-P Collared (STD Stem sizes 00 - 10 and LAT Stem sizes 0 - 10); and
- Quadra-P Cemented (STD Stem sizes 0 8 and LAT Stem sizes 0 8). ●
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 Quadra-P, Quadra-P short neck, and Quadra-P Collared are cementless stems manufactured from Titanium-Niobium alloy with a Titanium plasma spray coating (MectaGrip) on the proximal area and HA coating on the shaft. The Quadra-P Cemented stems manufactured from high nitrogen stainless steel.
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, K120521 and K122911), 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), or MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115). or MectaCer Biolox Option Heads (K131518).
MectaCer Biolox Option Heads (K131518) cannot be combined with Quadra-P cemented stems, but only with the Quadra-P cementless stems.
V. Indications for Use
The hip prostheses QUADRA-P and QUADRA-P collared are designed for cementless use in total or partial hip arthroplasty, for primary or revision surgery. The hip prosthesis QUADRA-P cemented 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
- 0 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 Quadra-P implants and the predicate devices share the following characteristics:
- CCD angle;
- materials of construction; ●
- coating;
- biocompatibility; ●
- device usage; ●
- sterility; ●
- shelf life; and
- packaging.
The Quadra-P femoral stems are technologically different from the predicate devices with respect to size and stem lengths.
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
- o 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);
- o 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 o Partial And Total Hip Joint Prostheses - Part 6: Determination Of Endurance Properties Of Head And Neck Region Of Stemmed Femoral Components;
- static fatigue testing: ISO 7206-10:2003 Implants For Surgery -- Partial And Total o Hip-Joint Prostheses -- Part 10: Determination Of Resistance To Static Load Of Modular Femoral Heads; and
- pull off force testing: ASTM F2009-00 (Reapproved 2011) Standard Test Method o For Determining The Axial Disassembly Force Of Taper Connections Of Modular Prostheses.
- Pyrogenicity ●
- o Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter ) and pyrogen test according to USP chapter for pyrogenicity determination.
- o the subject devices are not labeled as non-pyrogenic or pyrogen free.
6
K192827 Page 4/4
Quadra-P Traditional 510(k)
Clinical Studies:
- No clinical studies were conducted.
VIII. Conclusion
The information provided above supports that 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 effective as the predicate devices Quadra-P (K181254) and Quadra C (K083558).