The Symmetric™ Total Knee System is intended for the resurfacing of the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem) and a polyethylene tibial insert and patellar component.

The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/molybdenum (CoCrMo). The femoral component will be available in eight sizes (1-8) and will have a central post (with a 5° valgus angle) and gussets to aid in rotational stability and to increase strength. It will be plasma sprayed with Commercially Pure Titanium (CPTi).

The TIBIAL TRAY is a symmetrically designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti 6Al-4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside broviding rotational stabilization and increased tray strength. Four screw holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting the UHMWPE tibial insert to be snapped into place. The tibial tray has 8 sizes (1-8) and is plasma sprayed with Commercially Pure Titanium (CPTi).

The TIBIAL INSERT is also a symmetrically designed component manufactured from Ultra-High Molecular Weight Polyethylene (ASTM F648). The inserts' articulating geometry is semiconstrained and is captured in the tibial tray by the mating capture features. The insert is available in nine thicknesses (10, 12, 14, 16, 18, 20, 25, 30, 35mm) and 8 sizes (1-8).

The METAPHYSEAL STEM is designed to be driven onto a tibial tray further increasing the fit and fill of the component allowing for a more stable system.

The REVISION STEM is designed to be driven onto a tibial tray or femoral component further increasing the stability of a revision component.

The PATELLAR COMPONENT is dome shaped and tracks nicely against the femoral component.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (from Predicate Devices)	Symmetric™ Total Knee System Performance (Reported)
Femoral Component
Width (mm)	58-82mm (Beacon), Similar (Profix)	50-86mm
Substrate Material	CoCr (Beacon, Profix)	CoCr
Coating	Sintered Beads (Beacon, Profix)	Ti Plasma Spray
Tibial Tray
ML-Width (mm)	63-88mm (Beacon), Similar (Profix)	49-84mm
Substrate Material	Titanium 6Al-4V (Beacon, Profix)	Titanium 6Al-4V
Coating	Sintered Beads (Beacon, Profix)	Ti Plasma Spray
Tibial Poly
Thickness w/ tray (mm)	10-20mm (Beacon), Similar (Profix)	10-35mm
Standard/Deep	Standard/Deep (Beacon, Profix)	Standard/Deep
Material	UHMWPE (Beacon, Profix)	UHMWPE
Metaphyseal Stem
Diameters	NA (Beacon), Similar (Profix)	18-24mm
Lengths	NA (Beacon), Similar (Profix)	50-63mm
Attachment Method	NA (Beacon), Morse Taper (Profix)	Morse Taper
Material	NA (Beacon), Titanium 6Al-4V (Profix)	Titanium 6Al-4V
Revision Stem
Diameters	NA (Beacon), Similar (Profix)	10-26mm
Lengths	NA (Beacon), Similar (Profix)	100-200mm
Fixation Method	NA (Beacon), Morse Taper (Profix)	Morse Taper
Material	NA (Beacon), Titanium 6Al-4V (Profix)	Titanium 6Al-4V
Patella
Disk Diameter (mm)	26-41mm (Beacon), Similar (Profix)	25-40mm
Material	UHMWPE (Beacon, Profix)	UHMWPE
Intended Use
Fixation Method	Cemented (Beacon, Profix)	Cemented
Indications	Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Failed conservative procedures (Beacon, Profix)	Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis, Failed conservative procedures
Overall Performance	Substantially equivalent to or better than predicate devices, with no new questions of safety or effectiveness.	Based on non-clinical testing results.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical data was utilized for the basis of substantial equivalence."
Therefore, there is no clinical test set, sample size, or data provenance related to clinical data. The evaluation was based solely on non-clinical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no clinical test set or ground truth derived from expert opinion on clinical cases was used. The substantial equivalence was determined through non-clinical testing and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed on human readers as no clinical data was used. The evaluation was based on device performance in non-clinical tests.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not directly applicable in the context of this traditional medical device (knee implant). The "standalone" performance here refers to the device's physical and mechanical properties as tested in a laboratory setting, without human interaction in a 'use' scenario beyond the testing parameters. The non-clinical testing performed is essentially a standalone evaluation of the device's material and design integrity.

7. Type of Ground Truth Used

The ground truth for proving substantial equivalence was established through:

Comparison to predicate device specifications: The physical dimensions, materials, and fixation methods were compared to those of the Beacon Cemented and Uncemented Total Knee System (K051510) and the Profix Total Knee System (K933958).
Non-clinical testing methodologies: Performance was assessed against established engineering standards and guidance documents, specifically "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA (dated January 16, 2003)."

8. Sample Size for the Training Set

Not applicable, as this is a medical device submission based on substantial equivalence through non-clinical testing and comparison to predicate devices, not an AI/machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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K080199 # '1/0

Section 5:

1. Submitted by: Submitter's Name Address:
  Establishment Registration#: Correspondent: Date:

2. Device Name:

Trade Name: Proprietary Name: Common Name: Classification Name:

3. Device Class

Regulatory Class: Product Code: Panel: Regulation Number:

4. Predicate Device:

510(k) Summary

21 CFR 807.92

Signal Medical Corporation 1000 Des Peres Road, Suite 140 St. Louis, MO 63131 P: 314-775-0518 F: 314-775-0524 1932213 Brian Katerberg; Leo Whiteside, MD; Louis Serafin, MD March 4, 2011

SymmetricTM Total Knee System Signal Medical Corp. Symmetric™ Total Knee System Knee Prosthesis - Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, metal/polymer (888.3560 - JWH)

Class II JWH Orthopedic 21 CFR 888.3560

Beacon Cemented and Uncemented Total Knee System (K051510), Profix Total Knee System (K933958) Similarities to these components are based on design, indications for use, and materials.

JUL 3 2008

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	Category	Symmetric TotalKnee System	Beacon Cementedand UncementedTotal Knee System	Profix Total KneeSystem
	510K #	K080199	K051510	K933958
	Fixation Method	Cemented	Cemented/less	Cemented
Femoral	Width (mm)	50-86mm	58-82mm	Similar
	Substrate Material	CoCr	CoCr	CoCr
	Coating	Ti Plasma Spray	Sintered Beads	Sintered Beads
TibialTray	ML-Width	49-84mm	63-88mm	Similar
	Substrate Material	Titanium 6Al-4V	Titanium 6Al-4V	Titanium 6Al-4V
	Coating	Ti Plasma Spray	Sintered Beads	Sintered Beads
TibialPoly	Thickness w/ tray	10-35mm	10-20mm	Similar
	Standard/Deep	Standard/Deep	Standard/Deep	Standard/Deep
	Material	UHMWPE	UHMWPE	UHMWPE
Metap-hysealStem	Diameters	18-24mm	NA	Similar
	Lengths	50-63mm	NA	Similar
	Attachment Method	Morse Taper	NA	Morse Taper
	Material	Titanium 6Al-4V	NA	Titanium 6Al-4V
RevisionStem	Diameters	10-26mm	NA	Similar
	Lengths	100 - 200mm	NA	Similar
	Fixation Method	Morse Taper	NA	Morse Taper
	Material	Titanium 6Al-4V	NA	Titanium 6Al-4V
Patella	Disk Diameter	25 - 40mm	26 - 41mm	Similar
	Material	UHMWPE	UHMWPE	UHMWPE
	Intended Use	Cemented	Cemented	Cemented

Predicate Device Comparison

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K080199 # 3/4

5. Device Description:

The METAPHYSEAL STEM is designed to be driven onto a tibial tray further increasing the fit and fill of the component allowing for a more stable system.

The REVISION STEM is designed to be driven onto a tibial tray or femoral component further increasing the stability of a revision component.

The PATELLAR COMPONENT is dome shaped and tracks nicely against the femoral component.

6. Device Intended Use:

The Symmetric™ Total Knee System consist of single use components intended for total knee arthroplasty with the following indications.

1. Osteoarthritis (for cemented use only)
1. Rheumatoid Arthritis (for cemented use only)
1. Traumatic Arthritis (for cemented use only)
1. Where the use of a more conservative procedure has failed or is unacceptable.

7. Performance Summary:

Non-Clinical Testing:

-Testing performed was consistent with Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented

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K08A99 #4/4

Prostheses; Guidance for Industry and FDA (dated January 16, 2003). Tests included poly push in, push off, and pull out; tibial tray and femoral fatigue; femoral-tibial and femoralpatellar joint stability; femoral-tibial and femoral-patellar contact area/contact stress; static tensile and torsional testing of the modular stem/trunnion junction; and fatigue testing of the modular stems in conjunction with both the femur and tibia.

Clinical Testing:

No clinical data was utilized for the basis of substantial equivalence.

Conclusions:

Based on the Symmetric Total Knee System having the same intended use, the results of the non-clinical tests being substantially equivalent to or better than those of at least one predicate device, and the indications for use being similar, we feel that there are no new questions of safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines forming the body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

MAR 1 1 2011

Signal Medical Corporation % Mr. Brian Katerberg Engineer 1000 Des Peres Road, Suite 140 Saint Louis, Missouri 63131

Re: K080199

Trade/Device Name: Symmetric Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH

Dated: July 01, 2008 Received: July 03, 2008

Dear Mr. Katerberg:

This letter corrects our substantially equivalent letter of July 03, 2008.

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 (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.

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

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Page 2 - Mr. Brian Katerberg

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Aling B. Rh
fur

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

Enclosure

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Section 4:

Indications for Use

510K Number: K080199

Device Name: SymmetricTM Total Knee Augments

Indications For Use:

The Symmetric™ Total Knee System consist of single use components intended for total knee arthroplasty with the following indications.

1. Osteoarthritis (for cemented use only)
1. Rheumatoid Arthritis (for cemented use only)
Traumatic Arthritis (for cemented use only) 3.
1. Where the use of a more conservative procedure has failed or is unacceptable.

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)

for M. Melkeson
(a. Oft)

(Div/sion Sign-Oft) (Division Sign-On) Surgical, Orthopedic,
Division of Surgical, Orthopedic, Division of Surgion ,
and Restorative Devices

Number K080199

510(k) Number

K080199

Regulation Number and Section

§ 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.