Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies
Tumor resections
Revision of previously failed total joint arthroplasty
Trauma
The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue

The METS® Smiles Total Knee Replacement is for cemented use only.

The METS® Smiles Total Knee Replacement and its components are for single use only

Device Description

The single use METS® Smiles Total Knee Replacement is intended for the replacement of diseased or deficient bone in the proximal tibia. The femoral component and tibial stems of the system are intended for cemented use only.

The system comprises of the following components:
• Small and standard anatomical femoral knee components with single sized stem for each femoral component;
• A range of tibial options in both small and standard sizes – plastic cased rotating hinge, metal cased rotating hinge or fixed hinge;
• A series of tibial and femoral plateau plates in both knee sizes;
• Hyper-extension bumper pad for soft hyper-extension stop for both knee sizes;
• A pair of bushes, axle and a circlip for both knee sizes.

The materials used in the manufacture of the systems include: titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).

AI/ML Overview

The provided text describes a medical device submission (K120992) for the METS® SMILES TOTAL KNEE REPLACEMENT system. It details the device, its intended use, indications for use, and a summary of non-clinical testing and clinical evaluation.

However, the document does not contain the specific information requested about acceptance criteria, reported device performance in a table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment methods for a study proving the device meets acceptance criteria.

The document states:

Non Clinical Testing: "The results of the non-clinical performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate devices. The Performance testing included: knee fatigue and wear test, disassembly force testing for the taper connections, ASTM F1800-07 testing."
Clinical Performance Conclusions: "Clinical evaluation was carried out based upon published papers and post market surveillance."
Substantial Equivalence: "The METS® Smiles Total Knee Replacement is equivalent to the JTS Extendible Implant, (K092138), AVL Hinge Knee (K051570) and the Repiphysis limb salvage system (K021489) predicate devices. The determination of substantial equivalence is based on the similarity of the intended use, indications for use, design / technological characteristics, materials of composition, method of sterilization, performance data and clinical evaluation."

This indicates that the submission relied on demonstrating substantial equivalence to predicate devices through a combination of non-clinical performance tests and a clinical evaluation based on existing literature and post-market surveillance of the predicate devices, rather than a de novo study with specific quantitative acceptance criteria for the new device.

Therefore, I cannot populate the requested table and answer the specific questions about a study with detailed acceptance criteria, sample sizes, expert involvement, and ground truth, as this information is not present in the provided text. The submission focuses on showing the new device is fundamentally similar and performs comparably to already approved devices.

Summary

{0}------------------------------------------------

K120992(11/2)

SEP 5 2012

SECTION 5:

510(K) SUMMARY

Preparation Date	5th September 2012
Trade Name	METS® SMILES TOTAL KNEE REPLACEMENT.
Classification Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented,Metal/Polymer
Applicant/Sponsor	Stanmore Implants Worldwide Ltd210 Centennial AvenueCentennial ParkElstreeWD6 3SJUnited KingdomPhone: + 44 (0) 20 8238 6503Facsimile: +44 (0) 20 8954 0351
Contact Person:	Nancy MacDonaldManager of Regulatory AffairsHealth Policy Associates Inc.Email: nmacdonald@healthpolicyassociates.comTel: (781) 329-2993Fax: (781) 329-2958
Equivalent to	JTS Extendible Implant, Stanmore Implants (K092138), AVLHinge Knee Biomet (K051570) and the Repiphysis LimbSalvage System Wright Medical (K021489)
Device Description	The single use METS® Smiles Total Knee Replacement isintended for the replacement of diseased or deficient bone in theproximal tibia. The femoral component and tibial stems of thesystem are intended for cemented use only.The system comprises of the following components:• Small and standard anatomical femoral knee componentswith single sized stem for each femoral component;• A range of tibial options in both small and standard sizes –plastic cased rotating hinge, metal cased rotating hinge orfixed hinge;• A series of tibial and femoral plateau plates in both kneesizes;• Hyper-extension bumper pad for soft hyper-extension stopfor both knee sizes;• A pair of bushes, axle and a circlip for both knee sizes.

{1}------------------------------------------------

K120992(z/z)

The materials used in the manufacture of the systems include: titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).

Intended Use

Indications for Use

Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis

1. Correction of varus, valgus or post traumatic deformity
  The METS® Smiles Total Knee Replacement is intended for the

replacement of diseased or deficient bone around the knee joint.

1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
1. Ligament deficiencies
1. Tumor resections
1. Revision of previously failed total joint arthroplasty
1. Trauma

The METS® Smiles Total Knee Replacement is for cemented use only.

The METS® Smiles Total Knee Replacement and its components are for single use only.

Non Clinical Testing

The results of the non-clinical performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate devices. The Performance testing included : knee fatigue and wear test, disassembly force testing for the taper connections, ASTM F1800-07 testing.

Clinical Performance Conclusions

Clinical evaluation was carried out based upon published papers and post market surveillance.

The METS® Smiles Total Knee Replacement is equivalent to the JTS Extendible Implant, (K092138), AVL Hinge Knee (K051570) and the Repiphysis limb salvage system (K021489) predicate devices. The determination of substantial equivalence is based on the similarity of the intended use, indications for use, design / technological characteristics, materials of composition, method of sterilization, performance data and clinical evaluation.

Performance Data (non-clinical and clinical)

Substantial Equivalence

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

Stanmore Implants Worldwide, Limited % Health Policy Associates, Incorporated Ms. Nancy MacDonald Manager of Regulatory Affairs 690 Canton Street, Suite 302 Westwood, Massachusetts 02090

SEP 5 2012

Re: K120992

Trade/Device Name: METS® SMILES TOTAL KNEE REPLACEMENT Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: August 2, 2012 Received: August 3, 2012

Dear Ms. MacDonald:

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

{3}------------------------------------------------

Page 2 - Ms. Nancy MacDonald

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 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,

Eiriel Keith

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

Enclosure

{4}------------------------------------------------

SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

METS® SMILES TOTAL KNEE REPLACEMENT.

Intended Use:

The METS® Smiles Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint.

Indications for Use:

Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or 1. traumatic arthritis
Correction of varus, valgus or post traumatic deformity 2.
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 3.
Ligament deficiencies 4.
રું. Tumor resections
Revision of previously failed total joint arthroplasty 6.
Trauma 7.
I Tauna
The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of 8. bone and soft tissue

The METS® Smiles Total Knee Replacement is for cemented use only.

The METS® Smiles Total Knee Replacement and its components are for single use only

Prescription Use______________________________________________________________________________________________________________________________________________________________

AND/ OR

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(Per 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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120992

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.