(241 days)
The ANATOMIC® Total Knee System is indicated for use in total knee arthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
- Post-traumatic loss of knee joint configuration and function;
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
- Revision of previous unsuccessful knee replacement or other procedure.
The ANATOMIC® Total Knee System is for single use only and is intended for implantation with bone cement only.
The ANATOMIC® Total Knee System belongs to the category of sliding posterior-stabilized total knee prostheses (PS, posterior-cruciate substituting).
The ANATOMIC® Total Knee System is intended for use as a semi-constrained replacement system. It consists of a femoral implant, a tibial implant and a patellar implant. The tibial implant consists of two components: tibial insert and tibial baseplate. The patellofemoral joint may be preserved or resurfaced with the patellar resurfacing implant.
The femoral implant comes in right and left versions and in various sizes. The tibial baseplate and tibial insert are symmetrical and can be used both for right and left sides. The tibial baseplate comes in various sizes. The tibial insert is available in various sizes and thicknesses.
The nominal size of the insert includes the thickness of the tibial baseplate. The standard keel (supplied in the tibial baseplate packaging) must be mounted and blocked on the implant by the surgeon before implantation.
The components are for cemented used only.
The selection of the appropriate implants can be made by using the recommendations of the surgical technique and by using the x-ray templates and trial implants supplied with the instrumentation.
Please note: The provided document describes the ANATOMIC® Total Knee System, which is a medical device (knee prosthesis). The request asks for information relevant to "AI/ML powered device" or "software" performance criteria. Since this document is for a mechanical implant and not an AI/ML powered device, many of the requested fields (like "AI vs without AI assistance," "number of experts for ground truth," "adjudication method," "sample size for training set," etc.) are not applicable and thus couldn't be extracted from the provided text.
Based on the provided document, here's an analysis of the acceptance criteria and study information for the ANATOMIC® Total Knee System:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the format typically used for software or AI/ML devices. Instead, it refers to a "substantial equivalence" conclusion based on a comparison to predicate devices and adherence to relevant standards through non-clinical testing.
The comparison table (Table 1 on pages 4-6) lists numerous characteristics and states "YES" under the "Substantial equivalence?" column for each feature, indicating that the device's characteristics are considered equivalent to the predicate devices.
Key areas covered by the non-clinical testing for substantial equivalence:
| Acceptance Criteria Category (Derived from Testing Type) | Reported Device Performance (as implied by "Substantial Equivalence") |
|---|---|
| Tibial Baseplate Fatigue | Met required fatigue strength per FDA guidance. |
| Insert (post) Fatigue | Met required fatigue strength per FDA guidance. |
| Wear | Demonstrated acceptable wear characteristics. |
| Range of Motion | Achieved intended range of motion (High flexion = 130° max). |
| Constraints Femoro-Tibial | Demonstrated appropriate femoro-tibial constraints. |
| Constraints Patello-Femoral | Demonstrated appropriate patello-femoral constraints. |
| Contact Area/Stress Femoro-Tibial | Exhibited acceptable contact area and stress distribution. |
| Contact Area/Stress Patello-Femoral | Exhibited acceptable contact area and stress distribution. |
| Interlock Strength insert/Baseplate | Demonstrated sufficient interlock strength. |
| UHMWPE Material Properties | Conformed to test standards (ISO 5834-2, ASTM F648 for predicates). |
| Galvanic Effect on Corrosion | Assessed and demonstrated conformity to relevant standard. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical laboratory testing, not human patient data. Therefore, concepts like "test set sample size" (in terms of patients) and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this device. The tests are performed on physical samples of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of this document, refers to physical measurements and engineering standards, not expert evaluation of clinical data.
4. Adjudication method for the test set
Not applicable. This concept applies to human reader studies or clinical trials, not non-clinical laboratory testing of a mechanical implant.
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
Not applicable. This is a mechanical implant, not an AI/ML powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical implant, not an AI/ML powered device.
7. The type of ground truth used
The ground truth for the non-clinical tests is based on established engineering standards and regulatory guidance (e.g., FDA Guidance Class II/Special Controls Guidance Document Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 16, 2003, and test standards for materials like ISO 5832-4, ASTM F75, ISO 5834-2, ASTM F648).
8. The sample size for the training set
Not applicable. This is a mechanical implant; there is no "training set" in the AI/ML sense. The "training" in manufacturing would refer to design, material selection, and process validation, which are not typically quantified by a "sample size" in this context.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
Amplitude Mireille Lemery Director, Quality and Regulatory Affairs 11 Cours Jacques Offenbach Valence, FR 26000 France
Re: K161414 Trade/Device Name: Anatomic Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 16, 2016 Received: December 19, 2016
Dear Mireille Lemery:
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161414
Device Name ANATOMIC® Total Knee System
Indications for Use (Describe)
The ANATOMIC® Total Knee System is indicated for use in total knee arthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis,
rheumatoid arthritis or post-traumatic arthritis;
-
Post-traumatic loss of knee joint configuration and function;
-
Moderate varus, valgus or flexion deformity in which the ligamentous structures can
be returned to adequate function and stability;
- Revision of previous unsuccessful knee replacement or other procedure.
The ANATOMIC® Total Knee System is for single use only and is intended for implantation with bone cement only.
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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Image /page/3/Picture/1 description: The image shows the logo for Amplitude. The logo features a stylized letter "A" in blue, with a small circle attached to the upper left side of the "A". Below the "A" is the word "AMPLITUDE" in black, with a small degree symbol to the right of the word.
510(k) Summary of Safety and Effectiveness Information Traditional 510(k) Premarket - ANATOMIC® Total Knee System
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
Date prepared: December 16th, 2016
| Assigned 510(k) number: | K161414 |
|---|---|
| Company: | AMPLITUDE11, cours Jacques Offenbach, Zone Mozart 226000 Valence, FRANCEPhone: +33 4 75 81 34 95Fax: +33 4 75 41 41 78 |
| Contact: | Mireille LEMERY |
| Trade/Proprietary Name: | ANATOMIC® Total Knee System |
| Classification Name: | Knee Prosthesis |
| Classification/Product Code: | 21 CFR 888.3560, Class II, Product Code JWH |
| Predicate Devices: | Scorpio® NRG® Knee, Howmedica Osteonics CorpK030978, K042343, K071991Freedom® Total Knee System, Maxx OrthopedicsInc. K082019, K090411 |
Service Client France
Porte du Grand Lyon 01700 Neyron - France Tél : +33 (0)4 37 85 19 19 Fax : +33 (0)4 37 85 19 18
1. Device Description
The ANATOMIC® Total Knee System belongs to the category of sliding posterior-stabilized total knee prostheses (PS, posterior-cruciate substituting).
The ANATOMIC® Total Knee System is intended for use as a semi-constrained replacement system. It consists of a femoral implant, a tibial implant and a patellar implant. The tibial implant consists of two components: tibial insert and tibial baseplate. The patellofemoral joint may be preserved or resurfaced with the patellar resurfacing implant.
Export Customer Service
11, cours Jacques Offenbach Zone Mozart 2 26000 Valence - France Tél : +33 (0)4 75 41 87 41 Fax : +33 (0)4 75 41 87 42
E-mail : amplitude@amplitude-ortho.com
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The femoral implant comes in right and left versions and in various sizes. The tibial baseplate and tibial insert are symmetrical and can be used both for right and left sides. The tibial baseplate comes in various sizes. The tibial insert is available in various sizes and thicknesses.
The nominal size of the insert includes the thickness of the tibial baseplate. The standard keel (supplied in the tibial baseplate packaging) must be mounted and blocked on the implant by the surgeon before implantation.
The components are for cemented used only.
The selection of the appropriate implants can be made by using the recommendations of the surgical technique and by using the x-ray templates and trial implants supplied with the instrumentation.
2. Intended Use
The ANATOMIC® Total Knee System is intended for replacement of the knee joint to reduce pain and restore knee function in comparison with preoperative status.
3. Indications for use
The ANATOMIC® Total Knee System is indicated for use in total knee arthroplasty as a result of:
- -Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
- -Post-traumatic loss of knee joint configuration and function;
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
- Revision of previous unsuccessful knee replacement or other procedure. -
The ANATOMIC® Total Knee System is for single use only and is intended for implantation with bone cement only.
Summary of technological characteristics 4.
| Table 1: Main features comparison | ||
|---|---|---|
| -- | ----------------------------------- | -- |
| Service Client FrancePorte du Grand Lyon01700 Neyron - FranceTél: +33 (0)4 37 85 19 19Fax: +33 (0)4 37 85 19 18 | MATERIALS | Femoralimplant | ANATOMIC® TotalKnee System | Scorpio® NRG®Knee | Freedom® TotalKnee System | Substantialequivalence? |
|---|---|---|---|---|---|---|
| Export Customer Service11, cours Jacques OffenbachZone Mozart 226000 Valence - FranceTél: +33 (0)4 75 41 87 41Fax: +33 (0)4 75 41 87 42 | Tibialbaseplate | CoCrISO 5832-4 | CoCrASTM F75 | CoCrASTM F75 | YES | |
| Tibialinsert | CoCrISO 5832-4 | CoCrASTM F75 | CoCrASTM F75 | YES | ||
| Tibialinsert | UHMW-PEISO 5834-2 | UHMW-PEASTM F648 | UHMW-PEASTM F648 | YES | ||
| Patellarimplant | UHMW-PEISO 5834-2 | UHMW-PEASTM F648 | UHMW-PEASTM F648 | YES | ||
| Employedtechnology | Posterior Stabilized | Posterior Stabilized | Posterior Stabilized | YES | ||
| Anchoring system | Cemented | Cemented | Cemented | YES | ||
| Intended Use | Total KneeReplacement | Total KneeReplacement | Total KneeReplacement | YES | ||
| Sterilizationmethod | Gamma sterilization | Gamma sterilization | Gamma sterilization | YES | ||
| Maximum flexion | High flexion = 130°max | High flexion = 130°max | High flexion = 155°max | YES | ||
| Femoral component features | ||||||
| Model | 9 sizes | 9 sizes | 8 sizes | YES | ||
| Dimensions | AP from 49.83 to72.86 mmML 56 from to 76.7mm | AP from 51 to 75mmML from 57 to 82mm | AP from 51 to 74mmML 54 from to 78mm | YES | ||
| Anchoring system | Cage's surfaceshave negativemacrostructuregrooves type andcones with a depthof 0.5 mm as wellas positivemacrostructurespyramid type with aheight of 0.5 mmThe surface incontact with bonecement is shot-blasted | Wafle structures witha depth of 0.6 mmThe surface incontact with bonecement is shot-blasted | Groove depth 0.8mmThe surface incontact with bonecement is shot-blasted | YES | ||
| Radius ofcurvature | Single radius ofcurvature from 0°to 100° flexion | Single radius ofcurvature from 0° to95° flexion | Single radius ofcurvature from 15°to 120° | YES | ||
| Insert component features | ||||||
| Model | 9 sizes x 6thickness | 5 sizes x 7 thickness | 8 sizes | YES | ||
| Thickness | Thickness: 10, 12,14, 16, 18 and 20mm with Tibial TrayMinimumPolyethyleneThickness: 6.8without Tibial Tray | Thickness: 8, 10, 12,15, 18, 21, 24 mmwith Tibial TrayMinimumPolyethyleneThickness: 6 withoutTibial Tray | N/K | YES | ||
| Insert minimumthickness (mm) | 6.9 +/-0.1 mm | 6 mm, toleranceunknown | N/K | YES | ||
| Service Client FrancePorte du Grand Lyon01700 Neyron - FranceTél : +33 (0)4 37 85 19 19Fax : +33 (0)4 37 85 19 18Export Customer Service11, cours Jacques OffenbachZone Mozart 226000 Valence - FranceTél : +33 (0)4 75 41 87 41Fax : +33 (0)4 75 41 87 42 | The anchoringsystem of theinsert onto thetibial baseplate | Peripheral locks atsix places (twoanterior clips,posteromedial,posterolateral,lateral and medialdovetails) | 2 posteriorundercuts1 anterior wirePeripheral lip | Peripheral locks atfive places (anterior,posteromedial,posterolateral,lateral and mediallocking) | YES | |
| Tibial component features | ||||||
| Model | 9 sizes | 8 sizes | 8 sizes | YES | ||
| Dimensions | AP from 39.09 to57.31 mm | AP from 40 to 58mm | AP from 40 to 54mm | YES |
E-mail : amplitude@amplitude-ortho.com
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E-mail : amplitude@amplitude-ortho.com
Internet : www.amplitude-ortho.com
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| ML from 60 to 88mm | ML from 61 to 88mm | ML from 59 to 78mm | ||
|---|---|---|---|---|
| Tibial traythickness (mm) | 3 mm | 2.5 mm | 3.3 mm | YES |
| Stem length | 41 mm | 30 to 40 mm | N/K | YES |
| Surface aspect | Area in contact withbone cement: shot-blastedSurface in contactwith tibial insert:mirror polished | Shot-blasted | Shot-blasted | YES |
| Patellar component features | ||||
| Model | 4 diameters | 6 models | 4 diameters | YES |
| Dimension | 30, 33, 36 and 39mm | 30, 32, 34, 36 and38 mm | 25, 28, 31 and 34mm | YES |
| Thickness | 8 mm | 8 to 10 mm | Unknown | YES |
| Patella fixation | Resurfacing patellacemented withthree pegs | Resurfacing patellaare cemented withthree pegs andgrooves for cement. | All-poly resurfacingpatella cementedwith three pegs | YES |
| Patella shape | Spherical domeshape forresurfacing patella | Spherical domeshape for UniversalPatella | Spherical domeshape forresurfacing patella | YES |
| Manufacturer | Amplitude | HowmedicaOsteonics Corp. | Maxx Orthopedics,Inc. |
The product subject of this premarket notification is substantially equivalent in design and functionality to the Scorpio® NRG® Knee (K030978) and Freedom® Total Knee System (K082019).
5. Non clinical testing
Functional testing was conducted in compliance with the FDA Guidance Class II/Special Controls Guidance Document Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA, issued January 16, 2003.
Specifically, the following non-clinical laboratory tests were performed to determine substantial equivalence:
-
Tibial Baseplate fatique test -
-
Insert (post) fatigue test -
-
Wear test -
-
Range of Motion -
-
Constraints Femoro-Tibial -
-
Constraints Patello-Femoral -
-
Contact Area/ Stress Femoro-Tibial -
-
Contact Area/ Stress Patello-Femoral -
- Interlock Strength insert/ Baseplate
E-mail :
Service Client France Porte du Grand Lyon
01700 Neyron - France Tél : +33 (0)4 37 85 19 19 Fax : +33 (0)4 37 85 19 18
Export Customer Service
11, cours Jacques Offenbach Zone Mozart 2 26000 Valence - France Tél : +33 (0)4 75 41 87 41 Fax : +33 (0)4 75 41 87 42
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The UHMWPE material properties have been characterized according to test standards to demonstrate the conformity of the material.
The galvanic effect on the corrosion of the assembly between the tibial baseplate and the standard keel has been assessed according to relevant standard to demonstrate the conformity of the assembly.
MRI compatibility has not been evaluated for the ANATOMIC® Total Knee System.
The results of these tests demonstrate the equivalence between the ANATOMIC® Total Knee System and the Scorpio® NRG® Knee (K030978) and Freedom® Total Knee System (K082019).
6. Substantial Equivalence Conclusion
The proposed ANATOMIC® Total Knee System is believed to be substantially equivalent to the predicate devices with the same intended use and the same technological characteristics.
Service Client France
Porte du Grand Lyon 01700 Neyron - France Tél : +33 (0)4 37 85 19 19 Fax : +33 (0)4 37 85 19 18
Export Customer Service
11, cours Jacques Offenbach Zone Mozart 2 26000 Valence - France Tél : +33 (0)4 75 41 87 41 Fax : +33 (0)4 75 41 87 42
E-mail : amplitude@amplitude-ortho.com
Internet : www.amplitude-ortho.com
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.