(90 days)
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No
The document describes a mechanical knee implant component and makes no mention of AI or ML technology.
Yes
The device is a component of a knee replacement system intended to treat conditions like arthritis and failed previous surgeries, which are medical conditions, thus making it a therapeutic device.
No
The device, Legion Stems with Holes, is described as revision stems used with components of a knee replacement system. Its intended use is for treating various forms of arthritis and failed knee surgeries, which are conditions, not for diagnosing them.
No
The device description clearly states the device is a physical implant (stems manufactured from titanium alloy) and does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (knee stems) intended to be used within the body during knee replacement surgery. It is a physical component of a medical device system, not a test performed on a sample outside the body.
The description focuses on the physical characteristics of the stems, their material, and their intended use in a surgical procedure to replace or revise a knee joint. This is the definition of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The subject Legion Stems with Holes are intended to be used with femoral and tibial components of the Legion Revision Knee System.
Indications:
The Revision Knee System Components are indicated for:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The subject stems are revision stems manufactured from titanium alloy which feature distal fixation holes. The stems will be available in a variety of lengths and diameters, and they will be used in conjunction with currently marketed femoral and tibial components of the Legion Revision Knee System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee joint
Indicated Patient Age Range
older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Smith & Nephew Legion Press-Fit Stem, Smith & Nephew TriGen Knee Nail
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.
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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).
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§ 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
510(k) Summary Smith & Nephew
DEC 0 6 2007
Submitter's Name: Submitter's Address: Submitter's Telephone Number: Contact Person: Date Summary Prepared: Trade or Proprietary Device Name: Common or Usual Name: Classification Name:
Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-5340 Megan Bevill September 6, 2007 Legion Stems with Holes Knee Prosthesis 21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Class II Orthopaedics/87/JWH
Device Description
Device Class: Panel Code:
The subject stems are revision stems manufactured from titanium alloy which feature distal fixation holes. The stems will be available in a variety of lengths and diameters, and they will be used in conjunction with currently marketed femoral and tibial components of the Legion Revision Knee System.
Intended Use and Indications
Intended Use:
The subject Legion Stems with Holes are intended to be used with femoral and tibial components of the Legion Revision Knee System.
Indications:
The Revision Knee System Components are indicated for:
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The constrained knee systems are designed for use in patients in primary and revision ধ: surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral ligament) are absent or incompetent.
Substantial Eguivalence
Predicate stems:
Smith & Nephew Legion Press-Fit Stem Smith & Nephew TriGen Knee Nail
1
The subject stems are substantially equivalent to the above named stems in indications for use, material, method of manufacture, and basic design principles. The distal fixation mechanism is substantially equivalent to the TriGen Knee Nail listed above
2
Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Public Health Service
DEC 0 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. Orthopaedic Division % Megan Bevill Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Re: K072531
Trade/Device Name: Legion Stem with Holes Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 6 2007 Received: September 7, 2007
Dear Ms. Bevill:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Megan Bevill
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ K07253 |
Device Name: Legion Stems with Holes
The Revision Knee System Components are indicated for:
-
- Rheumatoid arthritis.
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
-
- The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one on both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent.
Prescription Use × (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cukave Buchm
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number 072531