(233 days)
The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.
Total Hip Arthroplasty with the Mpres stem 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.
- Failure of previous hip surgery:
o Conservative hip surgery,
o Internal fixation,
o Arthrodesis,
o Hip resurfacing replacement.
Partial hip arthroplasty with the Mpres stem is indicated in the following cases:
- · Acute traumatic fracture of the femoral head.
- · Avascular necrosis of the femoral head.
· Primary pathology involving the femoral head but with a non-deformed acetabulum.
The Mpres Neck Preserving Stem is a cementless short femoral stem intended to be used in total or partial hip arthroplasty for primary or revision surgery with minimally invasive hip replacement techniques. The Mpres Neck Preserving Stem is made of titanium alloy (Ti6Al7Nb) according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite in compliance with ASTM F1185. It is available in 12 sizes (sizes 3-14) for each neck variation configuration: a standard 130° CCD angle or an high offset 123° CCD angle.
This document is a 510(k) Premarket Notification from the FDA regarding the "Mpres Neck Preserving Stem" hip prosthesis. This type of document is generally about establishing substantial equivalence to an existing predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel AI diagnostic would.
Therefore, the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or reader improvement with AI assistance, does not directly apply to this document's content.
The document focuses on demonstrating that the Mpres Neck Preserving Stem is substantially equivalent to legally marketed predicate devices based on technological characteristics and non-clinical performance data. It explicitly states that "No clinical studies were conducted."
However, I can extract information related to the performance data and the types of studies that were conducted to support the substantial equivalence claim.
Here's an adaptation of the requested information based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for a mechanical implant, performance is demonstrated through biomechanical testing and material characterization against established standards, rather than clinical performance metrics typically associated with diagnostic devices. The acceptance criteria are implicit in meeting the requirements of the cited ISO/ASTM standards.
| Performance Characteristic | Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|---|
| Design Validation | Adequate performance in simulated use (e.g., sawbone, cadaveric evaluation) | Mpres Sawbone Design validation report, Plastic Stem Impactor, cadaveric evaluation completed. |
| Pull-Off Test | Meet requirements of ASTM F2009-00:2005, ISO 5832-9:2007, ISO 5832-12:1996, ISO 7206-10:2003 | Test Report No.: 167.090722.10.1309 (EndoLab) and CeramTec AG Test Reports 3128, 3300. |
| Range of Motion (ROM) | Meet requirements of EN ISO 21535:2009 | Mpres evaluation of the ROM completed. |
| Neck and Shaft Fatigue | Meet requirements of ISO 7206-6:2013, ISO 7206-4:2010, ASTM F2068-15, ASTM F2996-13, ISO 5832-11 | EndoLab Test Report 167 201005 10 3284-part1-rev0, Accentus Test Report OTC357, Straight Cantilever Test Report. |
| Coating Validation | Meet requirements of ISO 5832-11 | Mpres Coating validation rationale completed. |
| Fretting Corrosion | Meet requirements of ISO 5832-11 and ISO 21534 | Mpres femoral stems Fretting Corrosion Rationale completed. |
| Pyrogenicity | Meet requirements of European Pharmacopoeia §2.6.14 (LAL test) and USP chapter <151> | Bacterial endotoxin test (LAL test) and Pyrogen test completed. Devices are not labeled as non-pyrogenic. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in terms of specific numbers of devices tested for each non-clinical study. The reports cited (e.g., "Endolab Test Report," "CeramTec AG Test Reports," "Accentus Test Report") would contain this detail, but it's not present in this summary. For "cadaveric evaluation," the number of cadavers is not given.
- Data Provenance: The testing appears to have been conducted by various external and internal labs (e.g., EndoLab, CeramTec AG, Accentus). The company, Medacta International SA, is based in Switzerland, and Medacta USA is in Tennessee, USA. The standards cited are international (ISO, ASTM, EN) and US (USP, European Pharmacopoeia). This indicates a varied provenance tied to international standards for medical device testing.
- Retrospective or Prospective: These non-clinical performance tests are "prospective" in the sense that they are specifically performed for the purpose of this submission and validate the current design. They are not observational studies on existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This concept does not apply to this type of device submission. There is no "ground truth" established by experts in the context of diagnosing or interpreting images, as this is a hip implant, not an AI diagnostic device. The "ground truth" for these tests is the adherence to established engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This concept does not apply. Adjudication methods are relevant for clinical studies or studies involving expert interpretation, which were not performed here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is designed for AI diagnostic aids, not for a hip implant. The document explicitly states: "No clinical studies were conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept does not apply. A hip implant is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is the performance against established engineering and material science standards (e.g., ISO, ASTM, EN, USP). For example, a fatigue test must demonstrate that the device can withstand a certain number of cycles at a specific load without failure, as defined by the standard.
8. The sample size for the training set
This concept does not apply. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This concept does not apply.
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September 22, 2021
Medacta International SA Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 83118
Re: K210263
Trade/Device Name: Mpres Neck Preserving Stem 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 Dated: August 16, 2021 Received: August 17, 2021
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.
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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 (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 mediation-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 Quality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name
Mpres Neck Preserving Stem
Indications for Use (Describe)
The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.
Total Hip Arthroplasty with the Mpres stem 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.
- Failure of previous hip surgery:
o Conservative hip surgery,
o Internal fixation,
o Arthrodesis,
o Hip resurfacing replacement.
Partial hip arthroplasty with the Mpres stem is indicated in the following cases:
- · Acute traumatic fracture of the femoral head.
- · 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) |
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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, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: September 21, 2021
II. Device
| Device Proprietary Name: | Mpres Neck Preserving Stem |
|---|---|
| Common or Usual Name: | Hip Prosthesis |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis |
| Primary Product Code: | LZO |
| Secondary product code: | MEH |
| Regulation Number: | 21 CFR 888.3353 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following primary predicate device:
-
MiniHip, K083312, Corin USA
In addition the following reference devices are cited within the submission: -
MiniHip, K111046, Corin USA
-
SMS Cementless Stem Extension, K201673, Medacta International SA
-
SMS Cementless Stem, K181693, Medacta International SA
-
MiniMAX, K170845, Medacta International SA
IV. Device Description
The Mpres Neck Preserving Stem is a cementless short femoral stem intended to be used in total or partial hip arthroplasty for primary or revision surgery with minimally invasive hip replacement techniques.
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The Mpres Neck Preserving Stem is made of titanium alloy (Ti6Al7Nb) according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite in compliance with ASTM F1185. It is available in 12 sizes (sizes 3-14) for each neck variation configuration: a standard 130° CCD angle or an high offset 123° CCD angle.
Identically to the reference devices (SMS Cementless Stem - K201673 and K181963), the Mpres Neck Preserving Stem can be combined with the CoCr ball head (K072857, K080885 and K103721), Endo Head (K111145), the MectaCer BIOLOX® forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).
V. Indications for Use
The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery.
Total Hip Arthroplasty with the Mpres stem 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.
- Failure of previous hip surgery: ●
- o Conservative hip surgery,
- Internal fixation, O
- o Arthrodesis,
- Hip resurfacing replacement. O
Partial hip arthroplasty with the Mpres stem is indicated in the following cases:
- Acute traumatic fracture of the femoral head. ●
- . Avascular necrosis of the femoral head.
- Primary pathology involving the femoral head but with a non-deformed acetabulum.
VI. Comparison of Technological Characteristics
The Mpres Neck Preserving Stem implants and the predicate device (Corin MiniHip, K083312 and K111046) are similar in the following characteristics:
- shape and design; ●
- cementless use;
- CP-Ti and HA coating; ●
- mirror polishing surfaces;
- biocompatibility;
- device usage;
- . gamma radiation sterile; and
- packaging. ●
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The Mores Neck Preserving Stem implants differ from the predicate device (Corin MiniHip. K083312 and K111046) as follow:
- sizes; .
- stem length:
- neck offset; and ●
- . materials.
Discussion
The shape and design, the indications for use as well as the coating, device usage, biocompatibility, sterility and shelf life are similar to the predicate devices (Corin MiniHip, K083312 and K111046). Medacta International SA has not made any change to the materials and coating, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the reference devices (K201673, K1819693 and K170845).
The comparison of technological characteristics and performance data provided within this submission, shows that there are no new risks associated with the subject devices design, and supports the substantial equivalence of the Mpres Neck Preserving Stem implants to the identified predicate devices.
Performance Data VII.
Based on the risk analysis, design validation and characterization testing were conducted to written protocols. The following validation and tests were provided in support of the substantial equivalence determination:
Non-Clinical Studies
- DESIGN VALIDATION ●
- Mpres Sawbone Design validation report O
- Plastic Stem Impactor, cadaveric evaluation O
- CHARACTERIZATION TESTING
- Pull-Off Test On CoCr Femoral Head according to Test Protocol IL 07.09.033 (per o ASTM F2009-00:2005, ISO 5832-9:2007 and ISO 5832-12:1996), EndoLab Test Report, No .: 167.090722.10.1309 (per ISO 7206-10:2003), CeramTec AG Test Reports 3128 (per ISO 5832-11 and ISO 7206-10) and 3300 (per ISO 7206-10).
- o Mpres evaluation of the ROM (per EN ISO 21535:2009).
- o Mpres Neck and Shaft Fatigue test according to Test Protocol IL 07.09.001 (per ISO 7206-6:2013 and ISO 7206-4:2010), Fatigue test worst case rationales (Neck worst case per ASTM F2068-15, ASTM F2996-13, ISO 5832-11 and ISO 7206-6:2013) (Shaft worst case per ASTM F2068-15, ISO 7206-4:2010, ASTM F2996-13 and ISO 5832-11), Endolab Test Report 167 201005 10 3284-part1-rev0 (per ISO 7206-6:2013), Accentus Test Report OTC357 Final Report Medacta and Straight Cantilever Test Report (per ISO 7206-4:2010).
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- 0 Mpres Coating validation rationale (per ISO 5832-11).
- 0 Mpres femoral stems Fretting Corrosion Rationale (per ISO 5832-11 and ISO 21534).
- PYROGENICITY: .
- 0 Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>)
- o Pyrogen test according to USP chapter <151> for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
Clinical Studies:
- No clinical studies were conducted. ●
VIII. Conclusion
It is demonstrated in the submission that the Mpres Neck Preserving Stem implants are substantially equivalent to the predicate devices.
§ 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.