K Number
K993371
Device Name
SADDLE SHAPED PATELLA
Date Cleared
1999-12-20

(74 days)

Product Code
Regulation Number
888.3560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The ADVANCE® Saddle Shaped Patella is for use with bone cement only.
Device Description
The ADVANCE® Saddle Shaped Patella is manufactured from UHMWPE (ASTM F 648). The patella is designed to be a product line extension to the existing ADVANCE® Knee System. It is designed to articulate with the surface geomery of the medial pivot femoral component. The design of the subject device provides better articulation and increased surface area. The patella is available in 3 sizes, that match the articulating geometry of the femoral component. All three patellae have the same diameter of 25mm.
More Information

ADVANCE Total Knee System Patella

Not Found

No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Yes
The device is indicated for use in surgical procedures to reduce pain and improve knee function, which are therapeutic interventions.

No

Explanation: This device is a patellar implant used in total knee arthroplasty to replace damaged knee components, not to diagnose a condition.

No

The device description clearly states it is manufactured from UHMWPE and is a physical implant (patella) for total knee arthroplasty.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description: The provided text describes a surgical implant (a patella component for total knee replacement). It is a physical device intended to be surgically placed within the body.
  • Intended Use: The intended use clearly states it's for "total knee arthroplasty" to address conditions like osteoarthritis and rheumatoid arthritis, and for revision procedures. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.

The device is a medical device, but specifically a surgical implant, not an in vitro diagnostic.

N/A

Intended Use / Indications for Use

Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

  1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
  2. inflammatory degenerative joint disease including rheumatoid arthritis;
  3. correction of functional deformity;
  4. revision procedures where other treatments or devices have failed; and
  5. treatment of fractures that are unmanageable using other techniques.
    The ADVANCE® Saddle Shaped Patella is for use with bone cement only.

Product codes

JWH

Device Description

The ADVANCE® Saddle Shaped Patella is manufactured from UHMWPE (ASTM F 648). The patella is designed to be a product line extension to the existing ADVANCE® Knee System. It is designed to articulate with the surface geomery of the medial pivot femoral component. The design of the subject device provides better articulation and increased surface area. The patella is available in 3 sizes, that match the articulating geometry of the femoral component. All three patellae have the same diameter of 25mm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee

Indicated Patient Age Range

skeletally mature patients

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)

Mechanical test data demonstrated that it exceeds the requirements for contact area and lateral stability compared to other knees currently available.

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

Not Found

Predicate Device(s)

ADVANCE Total Knee System Patella

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

DEC 2 0 1999

Intended Use Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The ADVANCE® Saddle Shaped Patella is for use with bone cement only. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)OR Over-The Counter Use
(Division Sign-Off)
Division of General Restorative Devices
510(k) NumberK993371