(75 days)
Not Found
No
The description focuses on the mechanical components and materials of a knee replacement system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
This device is a total knee replacement system intended to treat conditions like osteoarthritis and rheumatoid arthritis, which are considered therapeutic indications.
No
Explanation: The Apex Knee™ Modular Tibia System is a total knee replacement prosthesis, which is a therapeutic device used for treatment, not diagnosis. Its intended use is to replace failed knee components or correct deformities, not to identify or characterize a disease or condition.
No
The device description clearly details physical components of a knee replacement system, including tibial baseplates, stems, augments, and locking bolts. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "primary or revision total knee replacement" to treat conditions like osteoarthritis and rheumatoid arthritis. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components of a knee prosthesis (tibial baseplate, stems, augments) and how they are assembled and implanted. This aligns with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on in vitro testing.
Therefore, the Apex Knee ™ Modular Tibia System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Apex Knee ™ Modular Tibia System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.
Product codes
JWH, MBH
Device Description
The Modular Tibial Baseplate is offered in sizes 1 thru 6 and is a symmetrical design. It is 5mm thick, and accepts Tibial Stems and Augment Blocks on its inferior surface.
Modular Tibia Stems are available from 9-17mm diameter in lengths of 75,100 or 150mm. The stem mates to the Modular Tibial Baseplate via a Morse taper connection, secured by a Locking Bolt.
Modular Tibia Augments are available in, size 1 thru 6. Each Augment is 4mm thick, and may be placed on either the medial or lateral side of the baseplate. They may be stacked up to three high in equal or descending sizes to create either a uniform or stepped lateral profile. Bone cement should not be used between stacked augments. Once stacked the augments must be secured to the tibial tray using a locking bolt of appropriate length to match the height of the augment stack. The Tibial tray (tibial baseplate) - augment assembly is then cemented to the prepared tibia.
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
No clinical studies were performed.
Non-Clinical Test Summary:
- Augment Attachment Strength per ASTM F1814-97AR03.
- Fretting Analysis per ASTM F1800-07.
- Stem Attachment and Tray/Augment Attachment Strength ASTM F1814-97.
All samples tested met the acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K101994 (1/3)
510(k) Summary
SEP 2 8 2010
.
| Apex Knee ™ Modular Tibia System | 22 September, 2010 | ||
|---|---|---|---|
| Submitter | OMNI life science, Inc. | ||
| 50 O'Connell Way | |||
| E. Taunton MA 02718 | Contact | Radhika Pondicherry | |
| Regulatory Affairs | |||
| 774-226-1852 | |||
| (508) 822-6030 (fax) | |||
| Preparation Date | 22 September 2010 | ||
| Device Nam | |||
| Trade Name | Apex Knee ™ Modular Tibia System | ||
| Common/Classification | |||
| Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented | ||
| prosthesis | |||
| Regulatory Class | Class II per 21 CFR §888.3560 | ||
| Product Code | JWH, MBH | ||
| Legally Marketed | |||
| Predicate Device(s) | K060192- Apex Knee System, cleared 15Jul2006 | ||
| K094017- Apex Knee System Tibial Baseplate Augment, cleared 05Mar2010 | |||
| K080361- Biomet, Regenerex™ Tibial Component, cleared 21April2008 | |||
| Device Description | The Modular Tibial Baseplate is offered in sizes 1 thru 6 and is a symmetrical design. It is 5mm | ||
| thick, and accepts Tibial Stems and Augment Blocks on its inferior surface. | |||
| Modular Tibia Stems are available from 9-17mm diameter in lengths of 75,100 or 150mm. | |||
| The stem mates to the Modular Tibial Baseplate via a Morse taper connection, secured by a | |||
| Locking Bolt. | |||
| Modular Tibia Augments are available in, size 1 thru 6. Each Augment is 4mm thick, and may | |||
| be placed on either the medial or lateral side of the baseplate. They may be stacked up to | |||
| three high in equal or descending sizes to create either a uniform or stepped lateral profile. | |||
| Bone cement should not be used between stacked augments. Once stacked the augments | |||
| must be secured to the tibial tray using a locking bolt of appropriate length to match the | |||
| height of the augment stack. The Tibial tray (tibial baseplate) - augment assembly is then | |||
| cemented to the prepared tibia. | |||
| Indications for Use | The Apex Knee ™ Modular Tibia System is intended for use as a primary or revision total knee | ||
| replacement. | |||
| This prosthesis may be used for the following conditions, as appropriate: | |||
| • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular | |||
| necrosis | |||
| • Rheumatoid arthritis | |||
| • Correction of functional deformity | |||
| • Revision procedures where other treatments or devices have failed | |||
| The porous coated femoral component may be used cemented or uncemented (biological | |||
| fixation). The porous coated tibial baseplate component may be used uncemented (biological | |||
| fixation). All other femoral, tibial baseplate and patellar components are indicated for | |||
| cemented use only. | |||
| The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia | |||
| baseplate and cemented to the prepared tibia. |
:
·
1
Predicate Device Comparison
.
| | Apex Knee Modular
Tibial
(subject device) | Apex Tibial Baseplate
Augment
(K094017) | Biomet- Regenerex
Tibial Component
(K080361) |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | | |
| Intended Use | Primary and revision
total knee
replacement | Primary and revision
total knee
replacement | Painful and disabled
knee joint resulting
from osteoarthritis,
rheumatoid arthritis,
traumatic arthritis
where one or more
compartments are
involved. Correction
of varus, valgus, or
posttraumatic
deformity. Correction
or revision of
unsuccessful
osteotomy,
arthrodesis, or failure
of previous joint
replacement
procedure. |
| Design | | | |
| Modular Tibial
Baseplate
insert locking
mechanism | Dovetail rails for
engaging the
UHMWPE tibial
insert with a central
threaded hole for
receiving the locking
bolt | Dovetail rails for
engaging the
UHMWPE tibial insert
with a central
threaded hole for
receiving the locking
bolt | N/A |
| Modular Tibia
Stem, Keel and
Cap | Modular Stem, Keel
and Cap- Attaches to
the Tibial Baseplate
via a Morse taper
connection, secured
by a Locking Bolt.
Provides rotational
stability and a point
of fixation for the
locking bolt to thread
onto. | Monoblock Tibial
Baseplate and keel. | Modular press fit stem
- taper junction and
screw. |
| Modular Tibia
Augments | Symmetrical
Augments are
stackable and
flipable and attach to
the bottom of the
Tibial Baseplate. | Designed to mate with
and be cemented to
the Apex Knee System
Tibial Baseplate. | N/A |
| Modular Tibia
Augment Bolt | Locking bolt used to
secure the
attachment of the
Tibial Augments to
the Tibial Baseplate. | Locking bolt used to
attach Tibial
Augments,
polyethylene insert
and Tibial Baseplate. | N/A |
| Insert | Locking bolt used to | secure the attachment | |
| Retaining Bolt
(UHMWPE) | secure the
attachment of the
Insert to the Tibial
Baseplate | of the Insert to the
Tibial Baseplate | |
| Modular Tibia
Pegs | Attaches to the
threaded holes in the
bottom of the tibial
Baseplate. Modular
Peg provides
additional rotational
stability to the tibial
component when the
Tibial Augments are
not being used. | NA | Modular Tibial Pegs
used to stabilize the
Tibial Plate on the
tibial plateau. |
| Materials and Standards | | | |
| Knee
components | ASTM F75-Cobalt
chromium- Tibial
Baseplate, Tibial
Augments | ASTM F1537-
Wrought cobalt
chromium- Tibial
Baseplate | CoCrMo alloy-
Modular Pegs |
| | ASTM 136- Ti-6Al-4V
ELI titanium alloy-
Inset locking bolt,
Augment locking
bolt, Cap, Stem, Keel
and Pegs | ASTM 136-
Ti-6Al-4V ELI titanium
alloy- Tibial Baseplate
Augment | Titanium Alloy-
Modular press fit stem |
.
,
2
Augment Attachment Strength per ASTM F1814-97AR03 .
- Fretting Analysis per ASTM F1800-07 .
- Stem Attachment and Tray/Augment Attachment Strength ASTM F1814-97 .
All samples tested met the acceptance criteria.
No clinical studies were performed. Clinical Test Summary
Conclusions
Non-Clinical Test
Summary
The Apex Knee ™ Modular Tibịa System is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OMNI Life Science, Inc. c/o Ms. Radhika Pondicherry 50 O'Connell Way Suite 10 East Taunton, MA 02718
Re: K101994
SEP 2 8 2010
Trade/Device Name: Apex Knee Modular Tibia System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH
Dated: July 13, 2010 Received: July 15, 2010
Dear Ms. Pondicherry:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Radhika Pondicherry
forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For Pete D
Rumm
Rumm
Dep D.R
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K101994
K101999
SEP 28 2010
Device Name: Apex Knee ™ Modular Tibia System
The Apex Knee ™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:
- . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular Necrosis;
- . Rheumatoid arthritis;
- Correction of functional deformity; .
- . Revision procedures where other treatments or devices have failed.
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only. The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Smuta for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K101994