(136 days)
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Not Found
No
The summary describes a physical implant (femoral head) and its mechanical and wear properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a total hip component, specifically a femoral head, which is used in primary and revision hip surgery to treat damaged hips, indicating a therapeutic purpose.
No
Explanation: The device is an Oxinium Femoral Head, a component for total hip replacement, used in surgical procedures to treat damaged hips. Its primary function is to replace part of a joint, not to diagnose a condition.
No
The device description explicitly states that the Oxinium Femoral Heads are "metal alloy devices processed via a proprietary oxidation process," indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
The provided text describes a medical device, specifically Oxinium Femoral Heads, which are components used in total hip replacement surgery. The intended use is for surgical implantation to replace damaged hip joints.
In vitro diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform such tests. It is a physical implant used in a surgical procedure.
N/A
Intended Use / Indications for Use
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Oxinium Femoral Heads are for single use only and can be used as part of cemented or uncemented total hip arthroplasty.
Product codes
JDI, LZO, LPH
Device Description
The Oxinium Femoral Heads are designed for use with femoral stems and acetabular components distributed by Smith & Nephew. The Oxinium Femoral Heads are metal alloy devices processed via a proprietary oxidation process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Hip
Indicated Patient Age Range
Not Found
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)
A review of the mechanical test data indicated that the Oxinium Femoral Heads are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Wear Particle Claims:
- Oxinium Femoral Heads generate 28% less crosslinked polyethylene particles as compared to equivalent sized CoCr femoral heads. Testing was performed in a multiaxial hip joint simulator for five million cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Crosslinked (10Mrad) Acetabular Liner (32mm I.D., 54-56 mm O.D., 11mm thickness, Size "F", 20° overhang), and Hyclone Modified Alpha Serum lubricant. The testing conducted did not detect any polyethylene particles with diameters less than 0.05 um. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
- Oxinium Femoral Heads generate 30% less conventional polyethylene particles as compared to equivalent sized CoCr femoral heads. Testing was performed in a multiaxial hip joint simulator for five million cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Acetabular Liner (32mm I.D., 54mm O.D., 11mm thickness, 20° overhang), and Hyclone Modified Alpha Serum lubricant. The testing conducted did not detect any polyethylene particles with diameters less than 0.05 um. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
- Oxinium Femoral Heads generate 63% less crosslinked polyethylene particles as compared to equivalent sized CoCr femoral heads under roughened conditions [1]. Testing was performed in a multi-axial hip joint simulator for five million cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Crosslinked (10Mrad) Acetabular Liner (32mm I.D., 54-56 mm O.D., 11mm thickness, Size "F", 20° overhang), and Hyclone Modified Alpha Serum lubricant. The testing conducted did not detect any crosslinked polyethylene particles with diameters less than 0.05 um. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
- Oxinium Femoral Heads generate 45% less conventional polyethylene particles as compared to equivalent sized CoCr femoral heads under roughened conditions [1]. Testing was performed in a multi-axial hip joint simulator for five million cycles ner individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Acetabular Liner (32mm I.D., 54mm O.D., 11mm thickness, 20° overhang), and Hvclone Modified Alpha Serum lubricant. The testing conducted did not detect any crosslinked polyethylene particles with diameters less than 0.05 µm. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
The roughened condition test is conducted in an effort to evaluate the effects of [1] third body wear on the wear performance of total joint devices. The femoral heads are tumbled with abrasive media prior to testing. This method has been found to simulate the scratch patterns seen on clinically retrieved femoral heads.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
JUL 2 5 2003
K030766
Page 1 of 3
Summary of Safety and Effectiveness Smith & Nephew, Inc. Oxinium Femoral Heads: Additional Claims
Contact Person and Address
Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566
Device Description
The Oxinium Femoral Heads are designed for use with femoral stems and acetabular components distributed by Smith & Nephew. The Oxinium Femoral Heads are metal alloy devices processed via a proprietary oxidation process.
Device Classification Name
21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis:Class II 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II
21 CFR 888.3358 Hip joint metal/ polymer/metal semi-constrained porous coated uncemented prosthesis - Class II
Indications for Use
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Oxinium Femoral Heads are for single use only and can be used as part of cemented or uncemented total hip arthroplasty.
Mechanical and Clinical Data
A review of the mechanical test data indicated that the Oxinium Femoral Heads are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
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K030766
Page 2 of 3
Wear Particle Claims
The following marketing claims will be made for Oxinium Femoral Heads.
- Oxinium Femoral Heads generate 28% less crosslinked polyethylene particles as 1) compared to equivalent sized CoCr femoral heads. Testing was performed in a multiaxial hip joint simulator for five million cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Crosslinked (10Mrad) Acetabular Liner (32mm I.D., 54-56 mm O.D., 11mm thickness, Size "F", 20° overhang), and Hyclone Modified Alpha Serum lubricant. The testing conducted did not detect any polyethylene particles with diameters less than 0.05 um. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
- Oxinium Femoral Heads generate 30% less conventional polyethylene particles as 2) compared to equivalent sized CoCr femoral heads. Testing was performed in a multiaxial hip joint simulator for five million cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Acetabular Liner (32mm I.D., 54mm O.D., 11mm thickness, 20° overhang), and Hyclone Modified Alpha Serum lubricant. The testing conducted did not detect any polyethylene particles with diameters less than 0.05 um. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
-
- Oxinium Femoral Heads generate 63% less crosslinked polyethylene particles as compared to equivalent sized CoCr femoral heads under roughened conditions [1]. Testing was performed in a multi-axial hip joint simulator for five million cycles per individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Crosslinked (10Mrad) Acetabular Liner (32mm I.D., 54-56 mm O.D., 11mm thickness, Size "F", 20° overhang), and Hyclone Modified Alpha Serum lubricant. The testing conducted did not detect any crosslinked polyethylene particles with diameters less than 0.05 um. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
-
- Oxinium Femoral Heads generate 45% less conventional polyethylene particles as compared to equivalent sized CoCr femoral heads under roughened conditions [1]. Testing was performed in a multi-axial hip joint simulator for five million cycles ner individual test using a 32mm, +0 offset Oxinium Femoral Head or Smith & Nephew Universal CoCr femoral head articulating counterface; a Reflection Acetabular Liner (32mm I.D., 54mm O.D., 11mm thickness, 20° overhang), and Hvclone Modified Alpha Serum lubricant. The testing conducted did not detect any crosslinked polyethylene particles with diameters less than 0.05 µm. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms or performance.
- The roughened condition test is conducted in an effort to evaluate the effects of [1] third body wear on the wear performance of total joint devices. The femoral heads are tumbled with abrasive media prior to testing. This method has been found to simulate the scratch patterns seen on clinically retrieved femoral heads.
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030766 34 3 of 3
Substantial Equivalence Information
The substantial equivalence of the Oxinium Femoral Heads is substantiated by its similarities in design features, overall indications, and material composition as existing femoral head components distributed by Smith & Nephew, Inc.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.
Public Health Service
JUL 2 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mrs. Kim P. Kelly, MS Project Manager, Regulatory & Clinical Affairs Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116
Re: K030766 Trade/Device Name: Oxinium Femoral Heads Regulation Number: 21 CFR 888.3350, 888.3353, 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis, Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI, LZO, LPH Dated: May 1, 2003 Received: May 2, 2003
Dear Mrs. Kelly:
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
4
Page 2 - Mrs. Kim P. Kelly, MS
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
L-Mark A. Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO30766 age 1 ot
Oxinium Femoral Heads: Additional Claims Indications Statement
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period: nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The Oxinium Femoral Heads are for single use only and can be used as part of cemented or uncemented total hip arthroplasty.
for Mark N. Wilkinson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KO30766 510(k) Number __
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
OR (Per 21 CFR 801.109) Over-The Counter Use