(101 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.
Yes
The device is a hip prosthesis, which is designed to replace a painful or disabled hip joint, thereby restoring function and alleviating symptoms. This directly addresses medical conditions and aims to improve patient health, classifying it as a therapeutic device.
No.
The device described is a hip prosthesis, which is an implant used for hip replacement surgery. Its purpose is to replace damaged hip joints, not to diagnose a medical condition.
No
The device description clearly details a physical hip implant made of titanium alloy and stainless steel, with various coatings and components. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a hip prosthesis for surgical implantation to replace a damaged hip joint. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials and components of a physical implant designed to be placed within the human body. It does not mention any reagents, test strips, or equipment used to analyze biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status or disease
- Using reagents or assays
- Being used in a laboratory setting
The device described is a medical device intended for surgical implantation, falling under the category of prosthetic implants.
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 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
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, KWY, LZY, LPH, JDI
Device Description
The Quadra-P implant subject of this submission is a line extension to the currently cleared Ouadra-P implants (K181254 and K192827).
The stem subject of this submission is a range extension of the Quadra-P Short Neck Standard stem cleared under K192827.
The Quadra-P implant subject of this submission is the Quadra-P Short Neck STD stem size 00, a coated cementless stem, commercial reference 01.12.249.
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.
Ouadra-P family includes cementless and cemented stems.
Quadra-P, Quadra-P Short Neck, and Quadra-P Collared implants are cementless stems made with a titanium alloy substrate (Ti6Al7Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy. The femoral stems have a Eurocone (12/14 taper) and polished necks.
Quadra-P, Quadra-P Short Neck, and Quadra-P Collared implants have an air plasma sprayed Titanium Y367 and Hydroxyapatite Osprovit (HA) dual layer coating on the proximal end of the shaft. The dual coating covers approximately 50% of the stem length. The distal part of the stem is coated with hydroxyapatite after sandblasting.
Also included in Quadra-P family, are 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), 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 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 Joint
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:
- Range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants
- Fatigue test (FEM): worst case justification regarding the fatigue test of the Ouadra-P Short Neck stems according to ISO 7206-4[2010]
- Fatigue test (FEM): worst case justification regarding the fatigue test of the Ouadra-P Short Neck stems according to ISO 7206-6.
- Pull off force testing: ASTM F2009-00 (Reapproved 2011) Standard Test Method For Determining The Axial Disassembly Force Of Taper Connections Of Modular Prostheses.
- DESIGN VALIDATION: Comparison between the new Quadra-P Short Neck stem family and the current Ouadra-P stems
- COATING TEST: ISO 13779-1 Second Edition 2008-10-01 Implants for Surgery Hydroxyapatite - Part 1: Ceramic Hydroxyapatite; and ASTM F1147-99 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings.
- 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; and the subject devices are not labeled as non-pyrogenic or pyrogen free.
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.
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118
Re: K202730
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: November 25, 2020 Received: November 27, 2020
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,
for
Vesa Vuniqi 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
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Indications for Use
510(k) Number (if known)
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 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)
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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 Bai, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: September 15, 2020 Date Revised: November 25, 2020
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 |
| 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
Primary predicate device:
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
- Medacta Total Hip Prosthesis System Quadra C (also referred to as "Quadra C"), ● K083558, Medacta International SA
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IV. Device Description
The Quadra-P implant subject of this submission is a line extension to the currently cleared Ouadra-P implants (K181254 and K192827).
The stem subject of this submission is a range extension of the Quadra-P Short Neck Standard stem cleared under K192827.
The Quadra-P implant subject of this submission is the Quadra-P Short Neck STD stem size 00, a coated cementless stem, commercial reference 01.12.249.
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.
Ouadra-P family includes cementless and cemented stems.
Quadra-P, Quadra-P Short Neck, and Quadra-P Collared implants are cementless stems made with a titanium alloy substrate (Ti6Al7Nb) according to ISO 5832-11 Second Edition 2014-09-15: Implants for Surgery - Metallic Materials - Part 11: Wrought Titanium 6-Aluminium 7-Niobium Alloy. The femoral stems have a Eurocone (12/14 taper) and polished necks.
Quadra-P, Quadra-P Short Neck, and Quadra-P Collared implants have an air plasma sprayed Titanium Y367 and Hydroxyapatite Osprovit (HA) dual layer coating on the proximal end of the shaft. The dual coating covers approximately 50% of the stem length. The distal part of the stem is coated with hydroxyapatite after sandblasting.
Also included in Quadra-P family, are 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), 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 MectaCer BIOLOX® Forte (K073337) or MectaCer BIOLOX® Delta Femoral Heads (K112115).
5
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
- Avascular necrosis of the femoral head
- Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty
VI. Comparison of Technological Characteristics
The Quadra-P implant subject of this submission and the predicate devices share the following characteristics:
- . CCD angle:
- Taper 12/14; ●
- materials of construction; ●
- coating; ●
- biocompatibility;
- device usage;
- sterility; ●
- shelf life; and
- packaging.
The Quadra-P implant subject of this submission is technologically different from the predicate devices as follows:
- neck offset;
- stem length;
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:
6
● PERFORMANCE TEST
- Range of motion (ROM): EN ISO 21535:2009 Non-Active Surgical Implants o Joint Replacement Implants - Specific Requirements for Hip-Joint Replacement Implants:
- Fatigue test (FEM): worst case justification regarding the fatigue test of the o Ouadra-P Short Neck stems according to ISO 7206-4[2010]
- Fatigue test (FEM): worst case justification regarding the fatigue test of the o Ouadra-P Short Neck stems according to ISO 7206-6.
- Pull off force testing: ASTM F2009-00 (Reapproved 2011) Standard Test o Method For Determining The Axial Disassembly Force Of Taper Connections Of Modular Prostheses.
- DESIGN VALIDATION
- Comparison between the new Quadra-P Short Neck stem family and the current o Ouadra-P stems
- COATING TEST ●
- o ISO 13779-1 Second Edition 2008-10-01 Implants for Surgery Hydroxyapatite - Part 1: Ceramic Hydroxyapatite; and
- o ASTM F1147-99 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings.
- 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; and
- the subject devices are not labeled as non-pyrogenic or pyrogen free. O
Clinical Studies
- No clinical studies were conducted
7
VIII. Conclusion
Based on the above information, the Quadra-P implants new size 00 Standard version, is 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 range extension implant is as safe and effective as the predicate devices, Quadra-P (K181254, Medacta International SA) and Quadra-P extension, (K192827, Medacta International SA)) (Only Cementless stems).