K Number
K094013
Device Name
HLS KNEETEC SYSTEM
Manufacturer
Date Cleared
2011-05-05

(492 days)

Product Code
Regulation Number
888.3560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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. 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.
More Information

Not Found

No
The summary describes a mechanical knee replacement device and its components, focusing on design improvements and performance testing. There is no mention of AI or ML technology.

Yes.
The device is a total knee replacement used for the relief of pain and significant disability, which directly addresses a health condition.

No

This device is described as a total knee replacement prosthesis, intended for surgical implantation to relieve pain and disability from osteoarthritis and rheumatoid arthritis. It is a therapeutic device, not one used for diagnosis.

No

The device description clearly states it is a prosthesis consisting of physical components (femoral implant, tibial implant, patella) intended for surgical implantation.

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

Here's why:

  • Intended Use: The intended use is for total knee replacement surgery to relieve pain and disability caused by osteoarthritis and rheumatoid arthritis, and for revision of existing knee prostheses. This is a surgical implant, not a diagnostic test performed on biological samples.
  • Device Description: The device is described as a semi-constrained replacement system consisting of physical components (femoral implant, tibial implant, patella) designed to be surgically implanted into the knee joint.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.

N/A

Intended Use / 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.

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

87 JWH

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.

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 was performed.

  • 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. Results: 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.
  • 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. Results: 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.
  • 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). Five fixed tibial trays were tested during 10 millions of cycles under maximum load of 237daN. Results: No damage nor ruptures have been noted on the five fixed tibial trays.
  • A comparative study was done to verify that the new design of the trochlea has equivalent congruence with the new patella. A comparative test was conducted 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. Results: 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.

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.

K013906, K984158, K991581, K833021, K912245, K984054

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

§ 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.

0