APEX KNEE MODULAR TIBIA SYSTEM

K101994 · Omnlife Science · JWH · Sep 28, 2010 · Orthopedic

Device Facts

• Record ID: K101994
• Device Name: APEX KNEE MODULAR TIBIA SYSTEM
• Applicant: Omnlife Science
• Product Code: JWH · Orthopedic
• Decision Date: Sep 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Apex Knee Modular Tibia System is a modular orthopedic implant for total knee replacement. Components include a symmetrical tibial baseplate (sizes 1-6), modular stems (9-17mm diameter; 75-150mm length), and stackable tibial augments (4mm thick). Components attach via Morse taper connections and locking bolts. The system provides rotational stability through modular stems or pegs. Used in surgical settings by orthopedic surgeons to replace damaged knee joints. The device is implanted to restore joint function and alleviate pain associated with degenerative or inflammatory joint disease. The modular design allows surgeons to customize the tibial construct based on patient anatomy and bone loss requirements.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, including augment attachment strength (ASTM F1814-97), fretting analysis (ASTM F1800-07), and stem/tray attachment strength (ASTM F1814-97). All samples met acceptance criteria.

Technological Characteristics

Materials: ASTM F75 Cobalt-chromium (baseplate, augments), ASTM F136 Ti-6Al-4V ELI titanium alloy (bolts, caps, stems, keels, pegs). Design: Modular tibial baseplate with Morse taper stem/keel connection and locking bolt. Symmetrical, stackable augments. Connectivity: None. Energy: None. Sterilization: Not specified.

Indications for Use

Indicated for primary or revision total knee replacement in patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or failed previous treatments/devices.

Regulatory Classification

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).

Predicate Devices

• Apex Knee System (K060192)
• Apex Knee System Tibial Baseplate Augment (K094017)
• Biomet, Regenerex™ Tibial Component (K080361)

Submission Summary (Full Text)

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# K101994 (1/3)

### 510(k) Summary

## SEP 2 8 2010

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| Apex Knee ™ Modular Tibia System | | 22 September, 2010 | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-----------------------------------------------------------------------------------|
| Submitter | OMNI life science, Inc.<br>50 O'Connell Way<br>E. Taunton MA 02718 | Contact | Radhika Pondicherry<br>Regulatory Affairs<br>774-226-1852<br>[phone] (fax) |
| Preparation Date | 22 September 2010 | | |
| Device Nam<br>Trade Name | Apex Knee ™ Modular Tibia System | | |
| Common/Classification<br>Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented<br>prosthesis | | |
| Regulatory Class | Class II per 21 CFR §888.3560 | | |
| Product Code | JWH, MBH | | |
| Legally Marketed<br>Predicate Device(s) | K060192- Apex Knee System, cleared 15Jul2006<br>K094017- Apex Knee System Tibial Baseplate Augment, cleared 05Mar2010<br>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<br>thick, and accepts Tibial Stems and Augment Blocks on its inferior surface.<br>Modular Tibia Stems are available from 9-17mm diameter in lengths of 75,100 or 150mm.<br>The stem mates to the Modular Tibial Baseplate via a Morse taper connection, secured by a<br>Locking Bolt.<br>Modular Tibia Augments are available in, size 1 thru 6. Each Augment is 4mm thick, and may<br>be placed on either the medial or lateral side of the baseplate. They may be stacked up to<br>three high in equal or descending sizes to create either a uniform or stepped lateral profile.<br>Bone cement should not be used between stacked augments. Once stacked the augments<br>must be secured to the tibial tray using a locking bolt of appropriate length to match the<br>height of the augment stack. The Tibial tray (tibial baseplate) - augment assembly is then<br>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<br>replacement.<br>This prosthesis may be used for the following conditions, as appropriate: | | |
| | • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular<br>necrosis<br>• Rheumatoid arthritis<br>• Correction of functional deformity<br>• Revision procedures where other treatments or devices have failed | | |
| | The porous coated femoral component may be used cemented or uncemented (biological<br>fixation). The porous coated tibial baseplate component may be used uncemented (biological<br>fixation). All other femoral, tibial baseplate and patellar components are indicated for<br>cemented use only.<br>The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia<br>baseplate and cemented to the prepared tibia. | | |

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#### Predicate Device Comparison

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| | Apex Knee Modular<br>Tibial<br>(subject device) | Apex Tibial Baseplate<br>Augment<br>(K094017) | Biomet- Regenerex<br>Tibial Component<br>(K080361) |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | | | |
| Intended Use | Primary and revision<br>total knee<br>replacement | Primary and revision<br>total knee<br>replacement | Painful and disabled<br>knee joint resulting<br>from osteoarthritis,<br>rheumatoid arthritis,<br>traumatic arthritis<br>where one or more<br>compartments are<br>involved. Correction<br>of varus, valgus, or<br>posttraumatic<br>deformity. Correction<br>or revision of<br>unsuccessful<br>osteotomy,<br>arthrodesis, or failure<br>of previous joint<br>replacement<br>procedure. |
| Design | | | |
| Modular Tibial<br>Baseplate<br>insert locking<br>mechanism | Dovetail rails for<br>engaging the<br>UHMWPE tibial<br>insert with a central<br>threaded hole for<br>receiving the locking<br>bolt | Dovetail rails for<br>engaging the<br>UHMWPE tibial insert<br>with a central<br>threaded hole for<br>receiving the locking<br>bolt | N/A |
| Modular Tibia<br>Stem, Keel and<br>Cap | Modular Stem, Keel<br>and Cap- Attaches to<br>the Tibial Baseplate<br>via a Morse taper<br>connection, secured<br>by a Locking Bolt.<br>Provides rotational<br>stability and a point<br>of fixation for the<br>locking bolt to thread<br>onto. | Monoblock Tibial<br>Baseplate and keel. | Modular press fit stem<br>- taper junction and<br>screw. |
| Modular Tibia<br>Augments | Symmetrical<br>Augments are<br>stackable and<br>flipable and attach to<br>the bottom of the<br>Tibial Baseplate. | Designed to mate with<br>and be cemented to<br>the Apex Knee System<br>Tibial Baseplate. | N/A |
| Modular Tibia<br>Augment Bolt | Locking bolt used to<br>secure the<br>attachment of the<br>Tibial Augments to<br>the Tibial Baseplate. | Locking bolt used to<br>attach Tibial<br>Augments,<br>polyethylene insert<br>and Tibial Baseplate. | N/A |
| Insert | Locking bolt used to | secure the attachment | |
| Retaining Bolt<br>(UHMWPE) | secure the<br>attachment of the<br>Insert to the Tibial<br>Baseplate | of the Insert to the<br>Tibial Baseplate | |
| Modular Tibia<br>Pegs | Attaches to the<br>threaded holes in the<br>bottom of the tibial<br>Baseplate. Modular<br>Peg provides<br>additional rotational<br>stability to the tibial<br>component when the<br>Tibial Augments are<br>not being used. | NA | Modular Tibial Pegs<br>used to stabilize the<br>Tibial Plate on the<br>tibial plateau. |
| Materials and Standards | | | |
| Knee<br>components | ASTM F75-Cobalt<br>chromium- Tibial<br>Baseplate, Tibial<br>Augments | ASTM F1537-<br>Wrought cobalt<br>chromium- Tibial<br>Baseplate | CoCrMo alloy-<br>Modular Pegs |
| | ASTM 136- Ti-6Al-4V<br>ELI titanium alloy-<br>Inset locking bolt,<br>Augment locking<br>bolt, Cap, Stem, Keel<br>and Pegs | ASTM 136-<br>Ti-6Al-4V ELI titanium<br>alloy- Tibial Baseplate<br>Augment | Titanium Alloy-<br>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 [phone] or [phone] 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)

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Smuta for mxn
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Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K101994