Predicate Devices

K080199, K043440, K053505, K072336, K053340, K953274

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the physical components and materials of knee implants and augments, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are non-clinical mechanical tests.

Therapeutic

Yes

The device, described as "Total Knee Augments", is intended to be attached to total knee implants during total knee arthroplasty to treat conditions like osteoarthritis and rheumatoid arthritis, which are therapeutic interventions.

Diagnostic

No

This device describes components for total knee replacement surgery (Symmetric Total Knee Augments) and their intended use in complementing existing knee implant systems. It does not mention any diagnostic functions, but rather focuses on physical components designed to provide bone support and fill voids during arthroplasty.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of Titanium 6Al-4V, such as wedges, stems, cones, sleeves, and offset trunnions, intended for surgical implantation. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended use clearly describes the device as components for total knee arthroplasty to address conditions like osteoarthritis and rheumatoid arthritis. This is a surgical procedure performed in vivo (within the body).
Device Description: The description details metallic implants (wedges, stems, cones, sleeves, offset trunnions) designed to be surgically implanted to provide structural support in the knee joint.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.

The device is a surgical implant used directly in the patient's body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications.

1. Osteoarthritis
1. Rheumatoid Arthritis
1. Traumatic Arthritis or correction of posttraumatic joint deformity
Where the use of a more conservative procedure has failed or is unacceptable. 4.
All components are for cemented use.
Additional indications for use:
Whenever a cone is used, a revision stem is to be used as well. .

Product codes (comma separated list FDA assigned to the subject device)

JWH

Device Description

The Symmetric™ Total Knee Augments are intended to complement the Symmetric Total Knee System. The system consists of metallic wedges, stems, cones, sleeves, and offset trunnions that can be used with the Symmetric Total Knee System to provide increased bone contact and support during total knee arthroplasty when more conservative methods have failed.

The FEMORAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral component. These wedges are made of Titanium 6Al-4V and have grit blasted surfaces where they are designed to be cemented to Symmetric Total Knee femoral implants and titanium plasma sprayed surfaces to provide good cemented fixation to bone. The components are available for the distal and posterior surfaces individually or combined. These wedges are symmetric so they will work on the medial or lateral side of either knee.

The TIBIAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the tibial component. These wedges are made of Titanium 6A1-4V and are designed for cemented fixation to Symmetric Total Knee tibial implants. The titanium plasma sprayed surfaces provide increased fixation for bone cement. The components are available in flat and wedged designs, and are able to be used on the medial or lateral side of the symmetric trays.

The TIBIAL and FEMORAL Cones are designed to fill voids remaining in the central bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral or tibial component. These cones are symmetrically designed components designed for cemented fixation around the trunnion or revision stem of a Symmetric total knee implant. The cones are made of Titanium 6Al-4V and are internally grit blasted for cement fixation against the implant and externally plasma sprayed to provide increased cemented fixation to bone.

The OFFSET TRUNNIONS are designed to be attached to the trunnion of the femoral or tibial component utilizing a Morse Taper, and then has a Morse Taper of its own to receive a revision stem. The offset stems are made of Titanium 6A1-4V, and are designed to provide adjustments in stem position with respect to the primary implants trunnion, allowing the stem to line up with the patient's medullary canal more effectively.

The COATED AND PARTIALLY COATED REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6Al-4V and are titanium plasma sprayed to provide increased fixation.

The RECTANGULAR REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6AI-4V and are available in non-coated and titanium plasma spray coated styles. The rectangular shape is designed to provide cortical bone support while reducing cancellous bone loss.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing: A writeup of the testing completed for this 510(k) is included in Section 18. Testing included compressive fatigue and static testing, torsional testing, and assembly/disassembly testing of the offset trunnion with a tray and stem.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K080199, K043440, K053505, K072336, K053340, K953274

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

SIGNAL MEDICAL CORPORATION

Image /page/0/Picture/1 description: The image shows a series of maritime signal flags, each corresponding to a letter of the alphabet. Below each flag is the corresponding letter, spelling out the word "ORTHOPAEDICS". The flags are arranged in a horizontal row, with each flag enclosed in a square frame. The letters are printed in a simple, sans-serif font.

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

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

Class II JWH Orthopedic 21 CFR 888.3560

SymmetricTM Total Knee System (K080199), Revision Knee System (K043440), Regenerex Ultra Porous Construct - Titanium Knee Augments (K053505), Regenerex Porous Titanium Sleeve Augments (K072336), Trabecular Metal Tibial Cone Augments and Trabecular Metal Femoral Cone Augments (K053340), Genesis II Total Knee System (K953274) Similarities to these components are based on design, indications for use, and materials.

MAR - 7 2011

1

| Category | Symmetric Total
Knee Augments | Symmetric Total
Knee System | Revision Knee
System | Regenerex™ Ultra
Porous Construct -
Titanium Knee
Augments | Regenerex™
Porous Titanium
Sleeve Augments Tibial and Femoral
Cone Augments | Genesis II Total
Knee System |----------------|--------- | 510K # | | Intended Use | Cemented | Femoral wedges | Thickness 5-15mm distal | NA | | Fixation Method to implant to implant | | Material | | Coating Spray ASTM F1580 | NA Titanium Porous
Coating ASTM F1580 | Regenerex™
Titanium Porous
Coating ASTM F1580 | NA | Femoral wedges | Thickness 5-15mm distal | NA | | Fixation Method to implant to implant | | Material | | Coating Spray ASTM F1580 | NA Titanium Porous
Coating ASTM F1580 | Regenerex™
Titanium Porous
Coating ASTM F1580 | NA | Femoral Cone | ML Width | | Height | | Fixation Method femoral component | NA femoral component
Regenerex™ | NA |
| | Material Metal™ | NA |
| | Coating Spray ASTM F1580 | NA Titanium Plasma
Spray ASTM F1580 | NA |
| Tibial Cone | ML Width | | Height | | Fixation Method component | NA component
Regenerex™ | NA |
| | Material Metal™ | NA |
| | Coating Spray ASTM F1580 | NA Titanium Plasma
Spray ASTM F1580 | NA |
| Trunnion | Offset Distance | | Extension Length | | Fixation Method | | Material | | Length | Stems | Diameter | | Fixation Method | | Material Titanium 6Al-4V Smith & Nephew
| Trabecular Metal™
| |
-------------------------|-------------------------------------|-------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------------|---------------------------------------------------|----|
K100370 | K080199 | K043440 | K053505 | K072336 | K053340 | K953274 | |
| Cemented | Cemented | Cemented/less | Cemented/less | Cemented/less | Cemented | |
| 5-10mm posterior,
| Similar | Similar | NA | NA | NA |
| Cemented to implant | NA | Cemented to implant | Cemented or screwed
| Cemented or screwed
| NA | NA |
| Titanium 6Al-4V | NA | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V | NA | NA |
| Titanium Plasma
| NA | Regenerex™
| NA |
| 5-10mm posterior,
| Similar | Similar | NA | NA | NA |
| Cemented to implant | NA | Cemented to implant | Cemented or screwed
| Cemented or screwed
| NA | NA |
| Titanium 6Al-4V | NA | Titanium 6Al-4V | Titanium 6Al-4V | Titanium 6Al-4V | NA | NA |
| Titanium Plasma
| NA | Regenerex™
| NA |
| 47-77mm | NA | NA | NA | NA | Similar | NA |
| 28-46mm | NA | NA | NA | NA | Similar | NA |
| Cemented onto
| NA | NA | NA | Cemented onto
| Titanium 6Al-4V | NA | NA | NA | NA | Tantalum Trabecular
| Titanium Plasma
| NA | NA | NA | Regenerex™
| 45-70mm | NA | NA | NA | NA | Similar | NA |
| 18-30mm | NA | NA | NA | NA | Similar | NA |
| Cemented onto tibial
| NA | NA | NA | Cemented onto tibial
| Titanium 6Al-4V | NA | NA | NA | NA | Tantalum Trabecular
| Titanium Plasma
| NA | NA | NA | Regenerex™
| 4mm | NA | NA | NA | NA | NA | NA |
| 50mm | NA | NA | NA | NA | NA | NA |
| Morse Taper | NA | NA | NA | NA | NA | NA |
| Titanium 6Al-4V | NA | NA | NA | NA | NA | NA |
| 100, 150, 200mm | NA | NA | NA | NA | NA | NA |
| 10 through 26mm | NA | NA | NA | NA | Similar | NA |
| Morse Taper | NA | NA | NA | NA | Similar | NA |
| Titanium 6Al-4V | NA | NA | NA | NA | Morse Taper
| NA |

Sec 5: Page 2 of 4

3/4/11

K100370

K100370 #²/₄

2

5. Device Description:

The Symmetric™ Total Knee Augments are intended to complement the Symmetric Total Knee System. The system consists of metallic wedges, stems, cones, sleeves, and offset trunnions that can be used with the Symmetric Total Knee System to provide increased bone contact and support during total knee arthroplasty when more conservative methods have failed.

The FEMORAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral component. These wedges are made of Titanium 6Al-4V and have grit blasted surfaces where they are designed to be cemented to Symmetric Total Knee femoral implants and titanium plasma sprayed surfaces to provide good cemented fixation to bone. The components are available for the distal and posterior surfaces individually or combined. These wedges are symmetric so they will work on the medial or lateral side of either knee.

The TIBIAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the tibial component. These wedges are made of Titanium 6A1-4V and are designed for cemented fixation to Symmetric Total Knee tibial implants. The titanium plasma sprayed surfaces provide increased fixation for bone cement. The components are available in flat and wedged designs, and are able to be used on the medial or lateral side of the symmetric trays.

The TIBIAL and FEMORAL Cones are designed to fill voids remaining in the central bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral or tibial component. These cones are symmetrically designed components designed for cemented fixation around the trunnion or revision stem of a Symmetric total knee implant. The cones are made of Titanium 6Al-4V and are internally grit blasted for cement fixation against the implant and externally plasma sprayed to provide increased cemented fixation to bone.

The OFFSET TRUNNIONS are designed to be attached to the trunnion of the femoral or tibial component utilizing a Morse Taper, and then has a Morse Taper of its own to receive a revision stem. The offset stems are made of Titanium 6A1-4V, and are designed to provide adjustments in stem position with respect to the primary implants trunnion, allowing the stem to line up with the patient's medullary canal more effectively.

The COATED AND PARTIALLY COATED REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6Al-4V and are titanium plasma sprayed to provide increased fixation.

The RECTANGULAR REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6AI-4V and are available in non-coated and titanium plasma spray coated styles. The rectangular shape is designed to provide cortical bone support while reducing cancellous bone loss.

3

KVO0320 *Mly

6. Device Intended Use:

The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications.

1. Osteoarthritis
1. Rheumatoid Arthritis
1. Traumatic Arthritis or correction of posttraumatic joint deformity
Where the use of a more conservative procedure has failed or is unacceptable. 4.

All components are for cemented use.

Additional indications for use:

Whenever a cone is used, a revision stem is to be used as well. .

Material Characteristics:

COMPONENT	CLEARED DEVICE	NEW DEVICE
Femoral Wedges	ASTM F1472	ASTM F1472
Tibial Wedges	ASTM F1472	ASTM F1472
Femoral and Tibial Cones	ASTM F1472	ASTM F1472
Offset Trunnion	ASTM F1472	ASTM F1472
(Partially) Coated Stems	ASTM F1472	ASTM F1472
Rectangular Revision Stems	ASTM F1472	ASTM F1472
Plasma Spray Coating	ASTM F1580	ASTM F1580

7. Performance Summary:

Non-Clinical Testing:

A writeup of the testing completed for this 510(k) is included in Section 18. Testing included compressive fatigue and static testing, torsional testing, and assembly/disassembly testing of the offset trunnion with a tray and stem.

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.

4

Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The seal is black and white.

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

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

MAR - 7 2011

Re: K100370

Trade/Device Name: Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: February 25, 2011 Received: March 2, 2011

Dear Mr. Katerberg:

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 r reade or actived 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 or uny I vithe Act's requirements, including, but not limited to: registration and listing (21

5

Page 2 - Mr. Brian Katerberg

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/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,

AZ. B. R.L.
fer

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

Enclosure

6

Section 4:

Indications for Use

510K Number: K100370

Device Name: SymmetricTM Total Knee Augments

Indications For Use:

The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications.

1. Osteoarthritis
1. Rheumatoid Arthritis
1. Traumatic Arthritis or correction of posttraumatic joint deformity
1. Where the use of a more conservative procedure has failed or is unacceptable.

All components are for cemented use.

Additional indications for use:

Whenever a cone is used, a revision stem is to be used as well. .
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 melkerson

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

K100370

510(k) Number