(88 days)
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 ioint 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; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The subject devices are intended for single use only.
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. 10/12 Taper Oxinium Femoral Heads. The subject devices are geometrically similar to the femoral head component in the Echelon Titanium Hip System cleared via submission K072817 and will include the addition of 32 mm and 36 mm diameter head sizes. This premarket notification seeks to add the 10/12 taper femoral head in oxidized zirconium material. Oxidized zirconium is the material of manufacture for 12/14 taper Femoral Heads cleared via submission K021673. The subject device will be offered in a size of 22 mm with offsets of -3, +0, and +3 mm; and is sizes ranging from 26 mm - 36mm, all with offsets of -5, +0, and +5 mm.
The provided document describes a 510(k) premarket notification for the "10/12 Taper Oxinium Femoral Heads" and its substantial equivalence to previously cleared predicate devices. It focuses on the physical and mechanical performance of the device rather than AI/software performance. Therefore, many of the requested fields related to AI model evaluation are not applicable or cannot be extracted from this document.
Here's the information that can be extracted from the provided text, along with an explanation for the inapplicable fields:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Aspects Tested) | Reported Device Performance |
|---|---|
| Pre-Fatigue and Post-Fatigue assembly and disassembly | Performs equal to or better than previously cleared devices (K021673, K072817) |
| Environmental Fatigue and Corrosion | Performs equal to or better than previously cleared devices (K021673, K072817) |
| Axial Fatigue | Performs equal to or better than previously cleared devices (K021673, K072817) |
| Range of Motion | Performs equal to or better than previously cleared devices (K021673, K072817) |
| Device Rigidity | Performs equal to or better than previously cleared devices (K021673, K072817) |
| Wear Performance | Performs equal to or better than previously cleared devices (K021673, K072817) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes physical and mechanical testing of a medical device (femoral head), not a software/AI device evaluated with a test set of data. Therefore, this information is not applicable. The "test set" here refers to physical components subjected to mechanical tests, not a data set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. Ground truth, in the context of expert review, typically relates to software predictions or image interpretations. For a physical device, performance is evaluated through engineering tests against established standards or predicate device performance, not expert consensus on data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in evaluating data, which is not relevant to the mechanical testing of a femoral head.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This study concerns the physical performance of a hip implant component, not an AI software or assistance system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. No algorithm or AI is described or evaluated in this document.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the performance data, the "ground truth" or reference for comparison is the performance of previously cleared predicate devices (Total Hip Femoral head - 12/14 Taper, K021673; and Echelon Titanium Hip System, K072817) in the specified mechanical and environmental tests. The underlying criteria for these tests would be derived from engineering standards and regulatory requirements for such devices.
8. The Sample Size for the Training Set
This information is not applicable. This document describes the testing of a physical medical device, not the training of an AI model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. There is no training set mentioned or implied as this is not an AI/software device.
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Summary of Safety and Effectiveness 10/12 Taper Oxinium Femoral Heads Smith & Nephew, Inc.
APR 1 1 2011
<110101
p.1/2
Date of Summary: January 11, 2011
Contact Person and Address Shereen Myers Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division
1450 East Brooks Road Memphis, Tennessee 38116 T (901) 399-6325
Name of Device: 10/12 Taper Oxinium Femoral Heads
Common Name: Femoral Head
Device Classification Name and Reference: 21 CFR 888.3353 Hip join metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II
Device Class: Class II
Panel Code: Orthopaedics/87
Predicate Devices: Total Hip Femoral Head - 12/14 Taper (K021673); and Echelon Titanium Hip System (K072817); Smith & Nephew Hip System (K022902); R3 Multi-Hole Shells and 36mm XLPE Liners (K092386); Total Hip Femoral Heads & Liners (K022958)
Device Description
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. 10/12 Taper Oxinium Femoral Heads. The subject devices are geometrically similar to the femoral head component in the Echelon Titanium Hip System cleared via submission K072817 and will include the addition of 32 mm and 36 mm diameter head sizes. This premarket notification seeks to add the 10/12 taper femoral head in oxidized zirconium material. Oxidized zirconium is the material of manufacture for 12/14 taper Femoral Heads cleared via submission K021673. The subject device will be offered in a size of 22 mm with offsets of -3, +0, and +3 mm; and is sizes ranging from 26 mm - 36mm, all with offsets of -5, +0, and +5 mm.
Intended Use
Total hip components are individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory ioint disease such as theumatoid 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; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The subject devices are intended for single use only.
Performance Data
Performance testing of the 10/12 taper Oxinium Femoral Heads yields results at least equivalent to previously cleared devices, Total Hip Femoral head - 12/14 Taper, submission K021673; and Echelon Titanium Hip System, submission K072817. Results of testing and analysis show that the subject device performs equal to or better than previously cleared devices in regards to:
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K110101
p. 2/2
- . Pre-Fatigue and Post-Fatigue assembly and disassembly
- . Environmental Fatigue and Corrosion
- . Axial Fatigue
- . Range of Motion
- Device Rigidity, and .
- . Wear Performance
Substantial Equivalence Information
Echelon Titanium Hip System
Smith & Nephew Hip System
Total Hip Femoral Heads and Liners
R3 Multi-Hole Shells and 35 mm XLPE Liners
The substantial equivalence of the 10/12 taper Oxinium Femoral Head is supported by its similarities in design features, overall indications, and material composition to the legally marketed devices for the total hip replacement listed in the following table:
| Description | SubmissionNumber | Clearance Date |
|---|---|---|
| Total Hip Femoral Head - 12/14 Taper | K021673 | 6/11/2002 |
5/15/2008
10/2/2002
11/3/2009
10/2/2002
Table 1: Previously cleared devices to which the subject device is substantially equivalent
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Ms. Shereen Myers Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116
APR 1 1 201
Re: K110101
Trade/Device Name: 10/12 Taper Oxinium Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: January 12, 2011
Received: January 13, 2011
Dear Ms. Myers:
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. 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 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
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Page 2 - Ms. Shereen Myers
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 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 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutliDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor.You/Industry/default.htm.
Sincerely vours
for D.A.
Oct. D.R.
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): K\0\0\ ( pg | / | )
Device Name: 10/12 Taper Oxinium Femoral Heads
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 ioint 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; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The subject devices are intended for single use only.
AND/OR Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 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.Melkman
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Device
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K110101
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.