This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also intended for the revision of knee prostheses.

The HLS Kneetec is intended for cemented use only.

Device Description

The HLS Kneetec prosthesis is intended for use as a semi-constrained replacement system. The HLS Kneetec cemented prosthesis with fixed tibial insert consists of three components intended to be used with bone cement: the femoral implant, the tibial implant and the patella. The tibial implant consists of two components: tibial insert and tibial tray, the tibial insert is clipsed on the tibial tray can be extended by a stem. The patella of the joint may be preserved or resurfaced with the patellar implant shared by all ranges of the HLS Kneetec prostheses.

The present device modification submission consists of the addition of a new prosthesis named HLS Kneetec to the HLS Knee range. The HLS Kneetec prosthesis is an evolution of the HLS Noetos System, CE marked in Europe since 1996 and cleared in the USA since 2001 (K013906). The HLS Kneetec prosthesis keeps HLS Noetos benefits and improves the compliance with patient's anatomy, with a new design to provide better bone coverage and greater interchangeability between sizes. The HLS Kneetec System completes the Tornier HLS range of knee implants.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Contact Area Stress / Pressure Test	The contact area stress and contact pressure between the new HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906- Equivalent size) must be equivalent.	No significant difference between HLS Kneetec size 2 and predicate HLS Noetos size 1 (K013906); contact area stress/pressure is equivalent.
Constraint Test (ASTM F1223)	Load displacement curves must be equivalent to the predicate device HLS Noetos (K013906).	No significant difference between HLS Kneetec size 2 and predicate HLS Noetos size 1 (K013906); frame of load displacement curves is equivalent.
Tibial Tray Fatigue Test (ASTM F1800:2007 & NF ISO 14879-1:2000)	The fixed tibial tray tested must resist 10 million cycles without any damages.	Five fixed tibial trays resisted 10 million cycles under maximum load of 237daN without any damage or ruptures. Therefore, the new tibial tray is conformed to the standards.
Patella Tracking Comparative Study	The contact area and trajectories must be equivalent to the predicate device HLS Noetos (K013906).	For HLS Kneetec and predicate HLS Noetos (K013906), the principle is the same; patella tracking is steady when moving the quadriceps in each position. Therefore, the designs are equivalent.

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

The provided document describes physical tests conducted on the device components, not a study involving human subjects or data from patients. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they relate to clinical studies are not applicable here.

Contact Area Stress / Pressure Test: HLS Kneetec size 2 (worst-case component) and HLS Noetos size 1 (equivalent size) were compared.
Constraint Test: HLS Kneetec size 2 (worst-case component) and HLS Noetos size 1 (equivalent size) were compared.
Tibial Tray Fatigue Test: Five fixed tibial trays of the HLS Kneetec were tested.
Patella Tracking Comparative Study: HLS Kneetec size 2 (worst-case component) and HLS Noetos size 1 (marketed predicate device, equivalent size) were compared.

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

This information is not applicable as the studies were non-clinical engineering tests (e.g., mechanical load tests, material comparisons). The "ground truth" was established based on engineering standards and direct physical measurements, not expert clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, these were non-clinical engineering tests, not studies requiring human adjudication of results. The results were based on direct physical measurements and compliance with established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done as this clearance is for a physical medical device (knee prosthesis) based on non-clinical testing for substantial equivalence to predicate devices, not for an AI/algorithm-based diagnostic or assistive system. Therefore, the effect size of human readers improving with AI vs. without AI assistance is not relevant or measurable in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. A standalone algorithm performance study was not done. The device is a physical knee prosthesis, and the evaluations performed were non-clinical engineering tests to demonstrate substantial equivalence.

7. The Type of Ground Truth Used

The "ground truth" for these non-clinical tests was based on:

Engineering Standards: Adherence to established mechanical testing standards (e.g., ASTM F1223, ASTM F1800:2007, NF ISO 14879-1:2000).
Direct Physical Measurement and Observation: Measurement of contact pressure, load displacement curves, and observation of damages after fatigue testing.
Comparative Performance to Predicate Devices: The performance of the new device was compared directly to that of the legally marketed predicate devices, with equivalence to the predicate serving as the "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. No "training set" in the context of machine learning or AI was used, as this is a physical medical device undergoing non-clinical engineering tests.

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

Not applicable. As there was no training set for an AI/algorithm, there was no ground truth for a training set to be established.

Summary

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<094013 #1

MAY - 5 2011

Summary of Safety and Effectiveness information Special 510(k) Premarket Notification - HLS KNEETEC System

Implants Chirur

Date prepared: May 5th, 2011

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

1) Device name

Trade name:	HLS KNEETEC System
Common name:	Total anatomical knee prosthesis
Classification name:	888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrainedcemented prosthesis.

2) Submitter

Tornier Rue Doyen Gosse 38330 Saint Ismier - France

3) Company contact

Tornier Mrs Séverine Bonneton Regulatory affairs Specialist 161, rue Lavoisier - Montbonnot 38334 Saint Ismier Cedex - France Tel: 00 33 4 76 61 35 00 Fax: 00 33 4 76 61 35 59 e-mail: severine.bonneton@tornier.fr

4) Classification

Device class:	Class II
Classification panel:	Orthopedic
Product code:	87 JWH

Equivalent / Predicate device

HLS Noetos System, Tornier, K013906 PFC Modular Plus Offset Tibial Tray, DePuy, Inc., K984158 NexGen Complete Knee Solution Legacy Posterior Stabilized, Zimmer, K991581 AGC Total Knee System, Biomet, Inc., K833021, K912245, K984054

Image /page/0/Picture/15 description: The image shows a logo with the letters 'TP' inside a hexagon. The letter 'T' is above the letter 'P', and they are both stylized with thick lines. The hexagon is outlined in black, and the letters are also in black. The logo appears to be a simple, geometric design.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

Section 5 - Page 1/ page 5

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

SIEGE SOCIAL: rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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K094013#2/5

Implants Chirurgicau

6) Device description

7) Materials

Femoral and tibial implants are manufactured from chromium cobalt alloy according to ISO 5832-4. The tibial plug is made of chromium cobalt alloy (CoCr) according to ISO standard 5832-7 or ISO standard 5832-12. Tibial inserts and the patella are made of ultra high molecular weight polyethylene (UHMWPE) according to ISO standard 5834-2.

8) Indications for use

This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. It is also intended for the revision of knee prostheses.

The HLS Kneetec is intended for cemented use only.

Image /page/1/Picture/10 description: The image shows a logo with a stylized letter "T" inside a hexagon. The "T" is designed with a thick vertical line and a horizontal bar at the top, and there is a small triangle above the horizontal bar. The hexagon is outlined with a dashed line, giving the logo a geometric and somewhat technical appearance.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 Section 5 - Page 21 page 5

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

SIEGE SOCIAL : rue du Doven Gosse - 38330 SAINT-ISMIER - FRANCE

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9) Summary of technological characteristics

Main features or systemcharacteristics		HLS KneetecSystem	HLS NoetosSystem	PFC ModularPlus OffsetTibial Tray	NexGenComplete Kneesolution LegacyPosteriorStabilized	AGCTotalKnee System

Materials	Femoral part	CoCr alloy	CoCr alloy	CoCr alloy	CoCr alloy	CoCr alloy+Titanium alloy
	Tibial insert	UHMWPE	UHMWPE	UHMWPE	UHMWPE	UHMWPE
	Tibial tray	CoCr alloy	CoCr alloy	Titanium alloy	Titanium alloy	CoCr alloy+Titanium alloy
	Patella	UHMWPE	UHMWPE	UHMWPE	UHMWPE	UHMWPE
Postero stabilized		yes	yes	yes	yes	yes
Sizes	Femoral part	9 Right9 Left	6 Right6 Left	6 Right6 Left	7 Right7 Left	6 Right6 Left
	Tibial insert	6 sizes6 thicknesses	6 sizes6 thicknesses	6 sizes8 thicknesses	8 sizes6 thicknesses	8 sizes6 thicknesses
	Tibial tray	7 sizes	6 sizes	6 sizes	8 sizes	8 sizes
	Patella	4 diameters	3 diameters	4 diameters	5 diameters	3 diameters
Method of fixation		Cemented	Cemented	Cemented	Cemented	Cemented(interlok)
Indications for use		Total kneereplacement	Total kneereplacement	Total kneereplacement	Total kneereplacement	Total kneereplacement
Terminal sterilization		Gamma	Gamma	Gamma	Gamma	Gamma
Manufacturer		TORNIER	TORNIER	DePuy	Zimmer	Biomet
K-number		K094013	K013906	K984158	K991581	K984054 K912245 K833021

The indications for use, the technical characteristics (manufacturing principle, method of fixation), the packaging and the sterilization process of the new HLS Kneetec System are similar or identical to the predicate devices.

The different technical characteristics of the new HLS Kneetec System compared to the predicate devices are a new design of the tibial tray, a new femoral trochlear groove design with a new patella dome design. The new design of the HLS Kneetec System compared to the predicate HLS Noetos (K0143906) provides a better bone coverage and a greater interchangeability between sizes.

Image /page/2/Picture/5 description: The image shows a logo inside of a hexagon. The logo appears to be a stylized letter "T" with a horizontal bar above it. The letter "T" is symmetrical and has a thick vertical line with two curved shapes on either side.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33 Section 5 - Page 3/ page 5

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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K094013*4/5

10) Non-clinical testing

Non-clinical testing was not necessary to determinate substantial equivalence between the new HLS Kneetec System and the cited predicate devices about:

The indications for use of the new HLS Kneetec System are identical to the indications for use of the predicate HLS Noetos System (K013906) and are very similar with the other predicates the PFC Modular Plus Offset Tibial Tray (K984158), the NexGen Complete Knee solution Legacy Posterior Stabilized (K991581) and the AGC Total Knee System (K833021, K912245, K984054).
. The intended use of the new HLS Kneetec System are identical to the intended use of predicates HLS Noetos System (K013906), PFC Modular Plus Offset Tibial Tray (K984158), NexGen Complete Knee solution Legacy Posterior Stabilized (K991581) and AGC Total Knee System (K833021, K912245, K984054).
-The raw materials of the new components of the HLS Kneetec System are identical to the raw materials of predicate HLS Noetos System (K013906).
-The fixation method of the new components of the HLS Kneetec is identical to the fixation method of the predicate components of the HLS Noetos (K013906), the PFC Modular Plus Offset Tibial Tray (K984158), the NexGen Complete Knee solution Legacy Posterior Stabilized (K991581) and the AGC Total Knee System (K833021, K912245, K984054).1379, and K091751).

Non clinical testing was necessary to determinate substantial equivalence between the new HLS Kneetec System and the cited predicate devices about:

-The new design of the femoral component:
A contact area stress / pressure test was performed to compare contact pressure on UHMWPE tibial insert between the HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906- Equivalent size) at each flexion angle.

The acceptance criteria is: the contact area stress and the contact pressure between the new HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906- Equivalent size) must be equivalent.

Results of verification: there is no significant difference between the HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906), the contact area stress /pressure is equivalent between the two prostheses.

So, the HLS Kneetec size 2 and the cleared HLS Noetos size 1(K013906) are equivalent.

Constraint test was performed to determine the constraint forces in anterior-posterior displacement, medial-lateral displacement and internal-external rotation between the HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906 - Equivalent size) according to ASTM F1223.

The acceptance criteria is: load displacement curves must be equivalent to the predicate device HLS Noetos (K013906).

Results of verification: there is no significant difference between the HLS Kneetec size 2 and the predicate HLS Noetos size 1 (K013906), the frame of load displacement curves is equivalent between the two prostheses.

So, the HLS Kneetec size 2 and the cleared HLS Noetos size 1(K013906) are equivalent.

Image /page/3/Picture/18 description: The image shows a logo with a stylized tree inside of a hexagon. The tree has a thick trunk and a wide, flat top. The logo is black and white and appears to be a simple line drawing. The hexagon provides a border around the tree symbol.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

Section 5 - Page 4/ page 5

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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K094013 # 5/5

The new tibial tray design:

A fatigue test on the fixed Kneetec tibial tray was done to validate the fixed tibial tray of the HLS Kneetec following existing standards (Fatigue tests: ASTM F1800:2007 & NF ISO 14879-1:2000). The acceptance criteria is: the fixed tibial tray tested must resist to 10 millions of cycles without any damages.

Results of verification: five fixed tibial trays have been tested during 10 millions of cycles under maximum load of 237daN. No damage nor ruptures have been noted on the five fixed tibial trays. So, the new tibial tray of the HLS Kneetec is conformed to the standards.

-The new femoral trochlear groove design with a new patella dome design:
A comparative study was done to verify that the new design of the trochlea has equivalent congruence with the new patella. We have conducted a comparative test versus the marketed predicate device HLS Noetos size 1(K013906) on the worst case component HLS Kneetec size 2 (equivalent size) to study the tracking of the patella under quadriceps motion.

The acceptance criteria is: the contact area and trajectories must be equivalent to the predicate device HLS Noetos (K013906).

Results of verification: for the HLS Kneetec and the predicate HLS Noetos (K013906) the principle is the same, the tracking of the patella is steady when moving the quadriceps in each position.

So, the design of the patella and the patella groove between the new HLS Kneetec and the cleared HLS Noetos (K013906) are equivalent.

Results of engineering studies referenced in this 510(k) submission demonstrate the proposed HLS Kneetec System device is substantially equivalent to the predicate devices.

11) Substantial equivalence conclusion

Based upon this comparative study, substantial equivalence of the new HLS Kneetec System to the already cleared components of the predicates can be demonstrated on the following grounds, according to the FDA's Guidelines for Substantial Equivalence Decision Making Process:

The components of the HLS Kneetec System are compared to the predicate devices. ।
The components of the HLS Kneetec System have the same intended use as the HLS Noetos System, the PFC Modular Plus Offset Tibial Tray, the NexGen Complete Knee solution Legacy Posterior Stabilized and the AGC Total Knee System and very similar indications for use.
Major technological characteristics are equivalent between the HLS Kneetec System and the predicate । devices:
- ﮯ Equivalence of general features
- -Equivalent polyethylene thickness
- -Equivalent materials
- -Equivalent means of fixation
- -Equivalent prosthetic dimensions

Therefore, in light of the above information, the company believes that the components of the HLS Knetter System may be cleared via the 510(k) notification process for use as a total knee prosthesis.

Image /page/4/Picture/22 description: The image shows a logo with a stylized letter 'T' inside a hexagon. The 'T' is constructed from geometric shapes, giving it a modern and abstract appearance. The logo has a slightly distressed or textured look, suggesting it may be from a vintage or worn design. The overall impression is simple, clean, and potentially representative of a brand or organization with a name starting with 'T'.

TORNIER S.A.S. 161, rue Lavoisier - Montbonnot 38334 SAINT-ISMIER CEDEX FRANCE

Tél. : 33 (0)4 76 61 35 00 Fax : 33 (0)4 76 61 35 33

Section 5 - Page 3/ page 5

S.A.S. au capital de 288 000 € SIRET : 070 501 275 000 13 R.C.S. : 070 501 275 CODE APE : 331 B

SIEGE SOCIAL : rue du Doyen Gosse - 38330 SAINT-ISMIER - FRANCE

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three human figures in the negative space of the eagle's body.

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

Tornier % Ms. Severine Bonneton Regulatory Affairs Specialist l 61, rue Lavoisier - Montbonnot 38334 Saint-Ismier Cedex - France

Re: K094013

MAY - 5 20:1

Trade/Device Name: HLS KNEETEC System Regulation Number: 21 CFR 88.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: April 26, 2011 Received: April 29, 2011

Dear Ms. Bonneton:

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 indictions 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 of ections 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 - Mrs. Severine Bonneton

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 100-1050.

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0fffices/ucm115809.html 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 tolli the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Aty B. R.h

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 (if known): K094013

Device Name: HLS KNEETEC System

Indications For Use:

The HLS Kneetec is intended for cemented use only.

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. pellerm

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

Page 1 of 1

510(k) Number K094013

Section 4

Tornier

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.