(241 days)
Not Found
No
The 510(k) summary describes a mechanical knee implant system and its components. There is no mention of software, algorithms, image processing, or any other indicators of AI/ML technology. The performance studies focus on mechanical and material properties.
Yes
The device is a total knee arthroplasty system, which is a surgical procedure to replace a damaged knee joint with artificial parts. This procedure is performed to alleviate pain and restore function in patients with painful and disabling joint disease, making it a therapeutic intervention.
No
Explanation: This device is a total knee replacement system, which is a prosthetic implant used in surgery, not a diagnostic tool. Its purpose is to replace diseased or damaged knee joints, not to identify or characterize medical conditions.
No
The device description clearly states it consists of physical implants (femoral, tibial, and patellar) and associated components, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The ANATOMIC® Total Knee System is a surgical implant designed to replace a damaged knee joint. It is physically implanted into the patient's body.
- Intended Use: The intended use is to treat painful and disabling knee joint disease through total knee arthroplasty (surgery).
The information provided clearly describes a medical device used in vivo (within the body) for surgical treatment, not a device used in vitro (outside the body) for diagnostic testing of specimens.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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)
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.
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
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).
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.
K030978, K042343, K071991, K082019, K090411
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.
Not Found
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
§ 888.3560 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.
0
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
1
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
2
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)
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
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: | AMPLITUDE |
| 11, cours Jacques Offenbach, Zone Mozart 2 | |
| 26000 Valence, FRANCE | |
| Phone: +33 4 75 81 34 95 | |
| Fax: +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 Corp |
| K030978, K042343, K071991 | |
| Freedom® Total Knee System, Maxx Orthopedics | |
| Inc. 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
4
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 France
Porte du Grand Lyon
01700 Neyron - France
Tél: +33 (0)4 37 85 19 19
Fax: +33 (0)4 37 85 19 18 | MATERIALS | Femoral
implant | ANATOMIC® Total
Knee System | Scorpio® NRG®
Knee | Freedom® Total
Knee System | Substantial
equivalence? |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------|-----------------------------|
| 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 | | Tibial
baseplate | CoCr
ISO 5832-4 | CoCr
ASTM F75 | CoCr
ASTM F75 | YES |
| | | Tibial
insert | CoCr
ISO 5832-4 | CoCr
ASTM F75 | CoCr
ASTM F75 | YES |
| | | Tibial
insert | UHMW-PE
ISO 5834-2 | UHMW-PE
ASTM F648 | UHMW-PE
ASTM F648 | YES |
| | | Patellar
implant | UHMW-PE
ISO 5834-2 | UHMW-PE
ASTM F648 | UHMW-PE
ASTM F648 | YES |
| | | Employed
technology | Posterior Stabilized | Posterior Stabilized | Posterior Stabilized | YES |
| | | Anchoring system | Cemented | Cemented | Cemented | YES |
| | Intended Use | Total Knee
Replacement | Total Knee
Replacement | Total Knee
Replacement | YES | |
| | Sterilization
method | 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 to
72.86 mm
ML 56 from to 76.7
mm | AP from 51 to 75
mm
ML from 57 to 82
mm | AP from 51 to 74
mm
ML 54 from to 78
mm | YES | |
| | Anchoring system | Cage's surfaces
have negative
macrostructure
grooves type and
cones with a depth
of 0.5 mm as well
as positive
macrostructures
pyramid type with a
height of 0.5 mm
The surface in
contact with bone
cement is shot-
blasted | Wafle structures with
a depth of 0.6 mm
The surface in
contact with bone
cement is shot-
blasted | Groove depth 0.8
mm
The surface in
contact with bone
cement is shot-
blasted | YES | |
| | Radius of
curvature | Single radius of
curvature from 0°
to 100° flexion | Single radius of
curvature from 0° to
95° flexion | Single radius of
curvature from 15°
to 120° | YES | |
| | Insert component features | | | | | |
| | Model | 9 sizes x 6
thickness | 5 sizes x 7 thickness | 8 sizes | YES | |
| | Thickness | Thickness: 10, 12,
14, 16, 18 and 20
mm with Tibial Tray
Minimum
Polyethylene
Thickness: 6.8
without Tibial Tray | Thickness: 8, 10, 12,
15, 18, 21, 24 mm
with Tibial Tray
Minimum
Polyethylene
Thickness: 6 without
Tibial Tray | N/K | YES | |
| | Insert minimum
thickness (mm) | 6.9 +/-0.1 mm | 6 mm, tolerance
unknown | N/K | YES | |
| 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 | The anchoring
system of the
insert onto the
tibial baseplate | Peripheral locks at
six places (two
anterior clips,
posteromedial,
posterolateral,
lateral and medial
dovetails) | 2 posterior
undercuts
1 anterior wire
Peripheral lip | Peripheral locks at
five places (anterior,
posteromedial,
posterolateral,
lateral and medial
locking) | YES | |
| | Tibial component features | | | | | |
| | Model | 9 sizes | 8 sizes | 8 sizes | YES | |
| | Dimensions | AP from 39.09 to
57.31 mm | AP from 40 to 58
mm | AP from 40 to 54
mm | YES | |
E-mail : amplitude@amplitude-ortho.com
5
E-mail : amplitude@amplitude-ortho.com
Internet : www.amplitude-ortho.com
6
| | ML from 60 to 88
mm | ML from 61 to 88
mm | ML from 59 to 78
mm | |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------|-----|
| Tibial tray
thickness (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 with
bone cement: shot-
blasted
Surface in contact
with 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 39
mm | 30, 32, 34, 36 and
38 mm | 25, 28, 31 and 34
mm | YES |
| Thickness | 8 mm | 8 to 10 mm | Unknown | YES |
| Patella fixation | Resurfacing patella
cemented with
three pegs | Resurfacing patella
are cemented with
three pegs and
grooves for cement. | All-poly resurfacing
patella cemented
with three pegs | YES |
| Patella shape | Spherical dome
shape for
resurfacing patella | Spherical dome
shape for Universal
Patella | Spherical dome
shape for
resurfacing patella | YES |
| Manufacturer | Amplitude | Howmedica
Osteonics 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
7
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