(75 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Apex Knee ™ Modular Tibia System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details non-clinical performance testing rather than clinical performance (e.g., diagnostic accuracy metrics). The acceptance criteria are implicit in that the samples must meet the standards.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Augment Attachment Strength (per ASTM F1814-97AR03) | "All samples tested met the acceptance criteria." |
| Fretting Analysis (per ASTM F1800-07) | "All samples tested met the acceptance criteria." |
| Stem Attachment and Tray/Augment Attachment Strength (per ASTM F1814-97) | "All samples tested met the acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for each non-clinical test (Augment Attachment Strength, Fretting Analysis, Stem Attachment, and Tray/Augment Attachment Strength).
The data provenance is from non-clinical bench testing, not human subjects. Therefore, details like country of origin for data or retrospective/prospective classification are not applicable.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This information is not applicable. The ground truth for this device (a knee implant system) is established through adherence to engineering standards and physical properties as assessed by bench testing, not expert interpretation of diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to resolving discrepancies in human expert assessments, which is not relevant for non-clinical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This type of study would involve human readers and is relevant for diagnostic or AI-assisted medical devices, not for assessing the mechanical properties of an orthopedic implant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The Apex Knee ™ Modular Tibia System is a physical orthopedic implant, not a software algorithm or AI device. Therefore, a "standalone algorithm performance" study is irrelevant in this context. The standalone performance relates to the mechanical integrity and functionality of the implant itself, which was assessed through the non-clinical tests.
7. Type of Ground Truth Used
The ground truth used for this device's evaluation was adherence to specified ASTM (American Society for Testing and Materials) standards for mechanical and material properties. This is a type of engineering and material science ground truth, not clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
This information is not applicable. As a physical orthopedic implant, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and prior successful designs.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. There is no "training set" for physical implant devices in the way there is for AI/ML algorithms. The design and manufacturing are based on established engineering principles, material properties, and successful predicate device designs, all of which are validated through non-clinical testing.
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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 WayE. Taunton MA 02718 | Contact | Radhika PondicherryRegulatory Affairs774-226-1852(508) 822-6030 (fax) |
| Preparation Date | 22 September 2010 | ||
| Device NamTrade Name | Apex Knee ™ Modular Tibia System | ||
| Common/ClassificationName | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cementedprosthesis | ||
| Regulatory Class | Class II per 21 CFR §888.3560 | ||
| Product Code | JWH, MBH | ||
| Legally MarketedPredicate Device(s) | K060192- Apex Knee System, cleared 15Jul2006K094017- Apex Knee System Tibial Baseplate Augment, cleared 05Mar2010K080361- 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 5mmthick, 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 aLocking Bolt.Modular Tibia Augments are available in, size 1 thru 6. Each Augment is 4mm thick, and maybe placed on either the medial or lateral side of the baseplate. They may be stacked up tothree 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 augmentsmust be secured to the tibial tray using a locking bolt of appropriate length to match theheight of the augment stack. The Tibial tray (tibial baseplate) - augment assembly is thencemented to the prepared tibia. | ||
| Indications for Use | The Apex Knee ™ Modular Tibia System is intended for use as a primary or revision total kneereplacement.This prosthesis may be used for the following conditions, as appropriate: | ||
| • Non-inflammatory degenerative joint disease, including osteoarthritis and avascularnecrosis• 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 (biologicalfixation). The porous coated tibial baseplate component may be used uncemented (biologicalfixation). All other femoral, tibial baseplate and patellar components are indicated forcemented use only.The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibiabaseplate and cemented to the prepared tibia. |
:
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Predicate Device Comparison
.
| Apex Knee ModularTibial(subject device) | Apex Tibial BaseplateAugment(K094017) | Biomet- RegenerexTibial Component(K080361) | |
|---|---|---|---|
| Intended Use | |||
| Intended Use | Primary and revisiontotal kneereplacement | Primary and revisiontotal kneereplacement | Painful and disabledknee joint resultingfrom osteoarthritis,rheumatoid arthritis,traumatic arthritiswhere one or morecompartments areinvolved. Correctionof varus, valgus, orposttraumaticdeformity. Correctionor revision ofunsuccessfulosteotomy,arthrodesis, or failureof previous jointreplacementprocedure. |
| Design | |||
| Modular TibialBaseplateinsert lockingmechanism | Dovetail rails forengaging theUHMWPE tibialinsert with a centralthreaded hole forreceiving the lockingbolt | Dovetail rails forengaging theUHMWPE tibial insertwith a centralthreaded hole forreceiving the lockingbolt | N/A |
| Modular TibiaStem, Keel andCap | Modular Stem, Keeland Cap- Attaches tothe Tibial Baseplatevia a Morse taperconnection, securedby a Locking Bolt.Provides rotationalstability and a pointof fixation for thelocking bolt to threadonto. | Monoblock TibialBaseplate and keel. | Modular press fit stem- taper junction andscrew. |
| Modular TibiaAugments | SymmetricalAugments arestackable andflipable and attach tothe bottom of theTibial Baseplate. | Designed to mate withand be cemented tothe Apex Knee SystemTibial Baseplate. | N/A |
| Modular TibiaAugment Bolt | Locking bolt used tosecure theattachment of theTibial Augments tothe Tibial Baseplate. | Locking bolt used toattach TibialAugments,polyethylene insertand Tibial Baseplate. | N/A |
| Insert | Locking bolt used to | secure the attachment | |
| Retaining Bolt(UHMWPE) | secure theattachment of theInsert to the TibialBaseplate | of the Insert to theTibial Baseplate | |
| Modular TibiaPegs | Attaches to thethreaded holes in thebottom of the tibialBaseplate. ModularPeg providesadditional rotationalstability to the tibialcomponent when theTibial Augments arenot being used. | NA | Modular Tibial Pegsused to stabilize theTibial Plate on thetibial plateau. |
| Materials and Standards | |||
| Kneecomponents | ASTM F75-Cobaltchromium- TibialBaseplate, TibialAugments | ASTM F1537-Wrought cobaltchromium- TibialBaseplate | CoCrMo alloy-Modular Pegs |
| ASTM 136- Ti-6Al-4VELI titanium alloy-Inset locking bolt,Augment lockingbolt, Cap, Stem, Keeland Pegs | ASTM 136-Ti-6Al-4V ELI titaniumalloy- Tibial BaseplateAugment | Titanium Alloy-Modular press fit stem |
.
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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.
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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
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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
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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
§ 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.