ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

K122870 · Conformis, Inc. · JWH · Jan 14, 2013 · Orthopedic

Device Facts

• Record ID: K122870
• Device Name: ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
• Applicant: Conformis, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jan 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iTotal® CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis. The Indications for Use include: Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee. Post traumatic loss of joint function. Moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants. Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The implant is intended for cemented use only.

Device Story

Patient-specific tricompartmental posterior cruciate ligament (PCL) retaining knee replacement system; utilizes patient CT or MR scans and proprietary software to design custom implants and manual surgical instruments. System comprises cobalt-chromium-molybdenum (CoCrMo) femoral component, metal-backed tibial tray, and Vitamin E-infused highly cross-linked UHMWPE (iPoly XE) tibial inserts and patellae. Used in clinical settings by orthopedic surgeons for cemented total knee arthroplasty. Patient-specific instruments assist in intra-operative positioning and bone cutting. Custom design aims to meet specific patient anatomic requirements; Vitamin E infusion in polyethylene components intended to reduce wear. Output is a physical implant system; clinical decision-making relies on surgeon assessment of patient imaging and surgical need.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included material properties (physical, mechanical, chemical), biocompatibility, and performance testing (wear, contact stress, interlock, subluxation). In-vitro knee simulator wear testing demonstrated significant gravimetric wear reduction for iPoly XE compared to conventional polyethylene inserts.

Technological Characteristics

Semi-constrained cemented prosthesis. Materials: CoCrMo alloy (femoral/tibial tray), Vitamin E-infused highly cross-linked UHMWPE (tibial inserts/patellae). Patient-specific design via CT/MR imaging. Manual surgical instruments (nylon jigs). Sterilization: VHP Gas Plasma. Connectivity: None (standalone).

Indications for Use

Indicated for patients with knee joint pain and disability due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, osteonecrosis, or post-traumatic loss of function. Suitable for patients with moderate varus, valgus, or flexion deformity where ligamentous structures remain functional, and for revision of failed prior knee implants. Contraindicated if anatomic landmarks for alignment are not identifiable on imaging.

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

• ConforMIS iTotal CR Knee Replacement System (K112780, K120316)
• Biomet E-Poly Tibial Bearings (K080528)
• DJO Surgical Highly Cross-Linked Vitamin E UHMWPE Tibial Insert and Patella (K091956, K103223, K113756)

Submission Summary (Full Text)

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K122870

# 510(K) SUMMARY

# JAN 1 4 2013

| Submitter's Name<br>and Address | ConforMIS Inc.<br>11 North Ave.<br>Burlington, MA 01803 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration<br>Number | 3004153240 |
| Date of Summary | December 27, 2012 |
| Contact Person | Amita S. Shah, Vice President, Quality & Regulatory Affairs |
| Telephone Number | [phone] |
| Fax Number | [phone] |
| Name of the Device | ConforMIS iTotal® Cruciate Retaining Knee Replacement System with<br>iPoly XE™ Tibial Inserts and patellae |
| Common or Usual<br>Name | Cruciate Retaining Total Knee Replacement<br>System |
| Classification<br>Name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis |
| Regulation Number | 21 CFR 888.3560 |
| Device<br>Classification | Product Code:<br>JWH, Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis.<br>OIY, Prosthesis, knee, patellofemorotibial, semi-constrained, cemented<br>polymer + additive/metal/polymer + additive. This generic type of device<br>includes prosthesis that have a femoral component mode of alloys, such as<br>cobalt-chromium-molybdenum, and a tibial component(s) and/or a<br>retropatellar resurfacing component made of ultra-high molecular weight<br>polyethylene plus an additive, such as a-tocopherol.<br>OOG, Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis. Intended to be used to assist in the<br>implantation of a specific knee arthroplasty device or a set of specific knee<br>arthroplasty devices. Indicated to include guiding alignment, making or<br>establishing cuts, selecting, sizing, attaching, positioning or orienting<br>implant components. |

Traditional 510(k) - iTotal® CR KRS- iPoly XE Inserts & Patellae

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| 510(k) Summary<br>continued | | |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Indications for Use | The iTotal® CR Knee Replacement System is intended for use as a total<br>knee replacement in patients with knee joint pain and disability whose<br>conditions cannot be solely addressed by the use of a prosthetic device<br>that treats only one or two of the three knee compartments, such as a<br>unicondylar, patellofemoral or bicompartmental prosthesis.<br>The Indications for Use include:<br>Painful joint disease due to osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis or osteonecrosis of the knee. Post traumatic loss of joint function. Moderate varus, valgus or flexion deformity in which the<br>ligamentous structures can be returned to adequate function and<br>stability. Failed osteotomies, hemiarthroplasties, and unicondylar,<br>patellofemoral or bicompartmental implants Revision procedures provided that anatomic landmarks necessary<br>for alignment and positioning of the implant are identifiable on<br>patient imaging scans. The implant is intended for cemented use only | |
| Identification of the<br>Legally Marketed<br>Devices<br>(Predicate Devices) | Device Class: | ConforMIS iTotal CR Knee Replacement System (KRS) |
| | Product Code: | JWH, OOG |
| | Regulation Number: | 21 CFR 888.3560 |
| | 510(k) number: | K120316, K120068, K113378, K112780, K103117,<br>K094050 |
| | Device Class: | Biomet E-Poly™ Tibial Bearings |
| | Product Code: | JWH, MBH, MBV, OIY |
| | Regulation Number: | 21 CFR 888.3560 |
| | 510(k) number: | K080528 |
| | Device Class: | DJO Surgical Highly Cross-Linked Vitamin E UHMWPE Tibial Insert and Patella |
| | Product Code: | JWH, MBH, OIY |

Traditional 510(k) – iTotal® CR KRS- iPoly XE™ Inserts & Patellae

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K122870

#### Regulation Number: 21 CFR 888.3560 K113756. K103223. K091956 510(k) number:

510(k) Summary continued

Device Description

The iTotal Cruciate Retaining Knee Replacement System (hereafter referred to as the "iTotal CR KRS") is a patient specific tricompartmental faceted posterior cruciate ligament (PCL) retaining knee replacement system. The iTotal CR KRS is a semi-constrained cemented knee implant which consists of a femoral, tibial and patellar component.

Using patient imaging (either CT or MR scans) and a combination of proprietary and off the shelf software a patient-specific implant and related instrumentation are designed, that best meet the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from cobalt chromium molybdenum ("CoCrMo") alloy. The tibial component includes a metal tray manufactured from CoCrMo alloy and either one or two polyethylene inserts that are manufactured from UHMWPE. The patellar component is also manufactured from UHMWPE.

ConforMIS is proposing a line extension of the current iTotal CR Knee Replacement System. The proposed line extension consists of providing tibial inserts and patellae made from a highly cross linked Vitamin E infused polyethylene (iPoly XE) similar to the predicate Biomet E-Poly™ Tibial Bearings (K080528) and the DJO Surgical Highly Cross-Linked Vitamin E UHMWPE Tibial Insert and Patella (K113756, K103223, K091956).

The iPoly XE tibial inserts and patellae will be manufactured from ultra high molecular weight polyethylene (UHMWPE) that is blended with Vitamin E (alpha-tocopherol), compression molded and then highly crosslinked. Other than the material, the iPoly XE Tibial inserts are identical in design to those cleared for the iTotal CR KRS via K120316. The iPoly XE patellae are also identical in design to those cleared via K112780.

For user convenience, and similar to the predicate iTotal CR KRS, accessory orthopedic manual surgical instruments designed for use with the modified iTotal CR KRS are provided to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total knee replacement components intra-operatively and in guiding the cutting of bone.

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K122870

The function and general design features of the patient specific ancillary
instruments remain similar to those described in the predicate iTotal CR
510ks (K120316, K120068, K113378, K112780, K103117, K094050).

Substantial
Equivalence:
The product subject of this premarket notification is substantially equivalent
in design and functionality to the iTotal Cruciate Retaining Knee
Replacement System (K112780 cleared December 15, 2011 and K120316
cleared April 19, 2012). The iPoly XE tibial bearing material is similar to
the material used in the Biomet E-Poly Tibial bearings (K080528 cleared
June 17, 2008), and the DJO Surgical Highly Cross-Linked UHMWPE
Tibial Insert and Patella (K091956 cleared September 28, 2010, K103223
cleared December 21, 2010 and K113756 cleared March 14, 2012)

The following non-clinical laboratory testing was performed to determine
substantial equivalence:

- Material properties of iPoly XE
- Physical and Mechanical testing
- Chemical Analysis
- Biocompatibility Testing of iPoly XE
- Performance testing of iPoly XE inserts and patellae
- Wear testing
- Contact area/contact stress testing
- Tibial implant interlock testing
- Patella subluxation testing

In-vitro knee simulator wear testing provided in the submission
demonstrated that the iTotal CR KRS with iPoly XE exhibited a significant
gravimetric wear reduction as compared to the iTotal CR KRS with
conventional polyethylene tibial inserts. The results of in-vitro wear

All testing has demonstrated the device is substantially equivalent to the predicate devices.

simulation testing have not been proven to quantitatively predict clinical

wear performance.

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| Total CR KRS with iPoly XE (This | Predicate iTotal CR KRS (K112780 and K120316) | Biomet E-Poly Tibial Bearings K080528 | Encore –DJO Surgical Highly Cross-linked Vitamin E UHMWPE Tibial Inserts and Patella K091956, K103223, K113756 | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Knee Replacement<br>for use as a total knee<br>replacements with knee joint pain<br>and disability whose conditions cannot be<br>solely addressed by the use of a prosthetic<br>device that treats only one or two of the<br>three knee compartments, such as a<br>unicondylar, patellofemoral or<br>bicompartmental prosthesis. The<br>indications for use include: | The iTotal® CR Knee Replacement System<br>is intended for use as a total knee<br>replacement in patients with knee joint pain<br>and disability whose conditions cannot be<br>solely addressed by the use of a prosthetic<br>device that treats only one or two of the<br>three knee compartments, such as a<br>unicondylar, patellofemoral or<br>bicompartmental prosthesis. The indications<br>for use include: | Indications for Use:<br>1. Painful and disabled knee joint resulting from<br>osteoarthritis, rheumatoid arthritis,<br>traumatic arthritis where one or more<br>compartments are involved.<br>2. Correction of varus, valgus, or posttraumatic<br>deformity..<br>3. Correction or revision of unsuccessful<br>osteotomy, arthrodesis, or failure of<br>previous joint replacement procedure. | Joint replacement is indicated for patients suffering<br>from disability due to: | |
| Painful joint disease due to<br>osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis or<br>osteonecrosis of the knee. Post traumatic loss of joint<br>function. Moderate varus, valgus or<br>flexion deformity in which the<br>ligamentous structures can be<br>returned to adequate function<br>and stability. Failed osteotomies,<br>hemiarthroplasties, and<br>unicondylar, patellofemoral or bi-<br>compartmental implants. | Painful joint disease due to<br>osteoarthritis, traumatic arthritis,<br>rheumatoid arthritis or<br>osteonecrosis of the knee. Post traumatic loss of joint<br>function. Moderate varus, valgus or flexion<br>deformity in which the<br>ligamentous structures can be<br>returned to adequate function<br>and stability. Failed osteotomies,<br>hemiarthroplasties, and<br>unicondylar, patellofemoral or bi-<br>compartmental implants. | For cemented and un-cemented use. | degenerative, post-traumatic or rheumatoid<br>arthritis; avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration,<br>particularly when there is patellofemoral<br>erosion dysfunction or prior patellectomy; moderate valgus, varus or flexion<br>deformities; Treatment of fractures that are<br>unmanageable using other techniques | |
| osteotomies,<br>hemiarthroplasties, and<br>unicondylar, patellofemoral or<br>compartmental implants. procedures provided<br>atomic landmarks<br>ary for alignment and<br>ing of the implant are<br>ble on patient imaging<br>only | The implant is intended for cemented use<br>only | | This device may also be indicated in the salvage of<br>previously failed surgical attempts. | |
| intended for cemented use | | | This device is intended to be used with the 3DKnee<br>System for cemented or uncemented applications. | |
| | | | Note: Patella component is only intended for<br>cemented use | |
| Characteristic | iTotal CR KRS with iPoly XE (This submission) | Predicate iTotal CR KRS (K112780 and K 120316) | Biomet E-Poly Tibial Bearings K080528 | Encore –DJO Surgical Highly Cross-linked Vitamin E UHMWPE Tibial Inserts and Patella K091956, K103223, K113756 |
| Intended for Cement Use Only | Yes | Yes | No | No |
| Product classification | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 (JWH) | 21 CFR 888.3560 | 21 CFR 888.3560 |
| Materials | Metal-Backed Tibial Components:<br>Tibial tray- CoCrMo Tibial Insert-Vitamin E infused highly cross-linked UHMWPE Patellar Component: Vitamin E infused highly cross-linked UHMWPE | Metal-Backed Tibial Components:<br>Tibial tray- CoCrMo Tibial Insert-UHMWPE Patellar Component: UHMWPE | Metal-Backed Tibial Components:<br>Tibial tray- CoCrMo Tibial Insert-Vitamin E infused highly cross-linked UHMWPE Patellar component- UHMWPE | Metal-Backed Tibial Components:<br>Tibial tray- CoCrMo Tibial Insert-Vitamin E infused highly cross-linked UHMWPE Patellar component - Vitamin E infused highly cross-linked UHMWPE |
| Design | Knee joint patellofemorotibial semi – constrained cemented prosthesis | Knee joint patellofemorotibial semi -constrained cemented prosthesis | Knee joint patellofemorotibial semi-constrained cemented prosthesis | Knee joint patellofemorotibial polymer/metal!/polymer semi-constrained cemented prosthesis |
| Tibial Implant | Configuration: Metal Backed Tibial Implant<br>Tibial Insert-Vitamin E infused highly cross-linked UHMWPE<br>Single or Dual inserts Insert sizes:6-16mm Profile: patient specific | Configuration: Metal Backed Tibial Implant<br>Tibial Insert- UHMWPE<br>Single or Dual inserts Insert sizes:6-16mm Profile: patient specific | Configuration: Metal Backed Tibial Implant<br>Tibial Insert-Vitamin E infused highly cross-linked UHMWPE<br>Single inserts Five insert sizes – five thickness/size | Configuration: Metal Backed Tibial Implant<br>Tibial Insert-Vitamin E infused highly cross- linked UHMWPE<br>Single inserts 9 insert sizes (2-12) and 5 thicknesses (9-19) |
| Instrumentation | Patient specific Nylon jigs | Patient specific Nylon jigs | Non Patient-specific jigs | Unknown |
| Principle of Operation | Cemented use<br>Fixed Bearing Design | Cemented use<br>Fixed Bearing Design | Cemented or un-cemented use<br>Fixed Bearing Design | Cemented or un-cemented use<br>Fixed Bearing Design |
| Posterior Cruciate Ligament (PCL) Sparing | Yes | Yes | Yes | Yes |
| Patient-Matched | Yes | Yes | No | No |
| Characteristic | iTotal CR KRS with iPoly XE (This submission) | Predicate iTotal CR KRS (K112780 and K120316) | Biomet E-Poly Tibial Bearings K080528 | Encore -DJO Surgical Highly Cross-linked Vitamin E UHMWPE Tibial Inserts and Patella K091956, K103223, K113756 |
| Packaging | Device components are individually double pouched using Tyvek® /film pouches which are sealed and labeled | Device components are individually double pouched using Tyvek® /film pouches which are sealed and labeled | Unknown | Unknown |
| Sterility Method/Assurance Level | VHP Gas Plasma 1x10-6 | VHP Gas Plasma 1x10-6 | Unknown | VHP Gas Plasma |
| Initial Shelf-Life | 6 months | 6 months | Unknown | Unknown |
| Labeled Non-pyrogenic | No | No | No | No |

raditional 510(k) – iTotal® CR KRS– iPoly XE Inserts & Patellae

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Traditional 510(k) – iTotal® CR KRS- iPoly XE™ Inserts & Patellae

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Traditional 510(k) – iTotal® CR KRS-- iPoly XE™ Inserts & Patellae

K12-2870

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K122870

| Description and | The determination of substantial equivalence for this device was based |
|-----------------|------------------------------------------------------------------------|
| Conclusion of | on a detailed device description and non-clinical laboratory testing. |
| Testing | Testing on the iPoly XE outlined below: |

| Property /Characteristic | Tests conducted |
|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic<br>Toxicity, Material Mediated Pyrogenicity, Sub Chronic Toxicity,<br>Genotoxicity, Muscle Implantation |
| Physical and Mechanical Properties | Small Punch Test, Fatigue Crack Growth Test, Izod Impact Test,<br>Static Tensile Test, Compressive Modulus Test |
| Chemical Properties | Scanning Electron Microscopy analysis, Differential Scanning<br>Calorimetry analysis, Free Radical Content, Oxidization Index,<br>Extraction analysis, Residue on extraction, Uniformity of radiation<br>dose, Cross-link Density, Vitamin E Content, Ash Content<br>Environmental Stress Cracking, |
| Performance Testing | Tibiofemoral Contact Area/Stress, Strength of Tibial interlock,<br>Patella Shear Test, Patella Tensile Test, Patellofemoral Contact<br>Area/Stress Test, Wear Testing per ISO 14243. Wear Testing<br>under abrasive conditions, Analysis of wear debris. |
| Electromagnetic Compatibility | Evaluation of the Safety and Compatibility of the iTotal CR Knee<br>Replacement System within the MRI Environment |
| Test results demonstrated that the device is safe and can be considered substantially equivalent to the | |

predicate device for the intended use.

## Safety and Performance

The determination of substantial equivalence for this device was based on a detailed device description and non-clinical laboratory testing. The testing demonstrated that the device is safe for its intended use and can be considered substantially equivalent to the predicate devices. Clinical data is not necessary to demonstrate substantial equivalence.

### Conclusion:

Based on the testing conducted, it is concluded that the iTotal Cruciate Retaining Knee Replacement System with iPoly XE tibial inserts and patellae is substantially equivalent to the iTotal Cruciate Retaining Knee Replacement System K112780 cleared December 15, 2011, K120316 cleared April 19, 2012, K080528 (Biomet) cleared June 17, 2008, K091956 (DJO Surgical) cleared September 28, 2010, K103223 (DJO Surgical) cleared December 21, 2010, and K113756 (DJO Surgical) cleared March 14, 2012.

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Image /page/8/Picture/0 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 an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Letter dated: January 14, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Conformis, Incorporated % Ms. Amita Shah Vice President, Ouality & Regulatory Affairs 11 North Avenue Burlington, Massachusetts 01803

Re: K122870

. Trade/Device Name: ConforMIS® iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)

Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: OIY, JWH, OOG Dated: December 6, 2012

Received: December 7, 2012

Dear Ms. Shah:

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

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#### Page 2 - Ms. Amita Shah

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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