(88 days)
No
The document describes a mechanical implant (femoral head) and its material properties and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a total hip component, intended to rehabilitate damaged hips, which aligns with the definition of a therapeutic device.
No
The device is a component of a total hip replacement system, indicated for surgical implantation to rehabilitate damaged hips. It is a treatment device, not a diagnostic one.
No
The device description clearly states the device is a physical component (femoral head) made of oxidized zirconium, intended for surgical implantation. It describes material properties and physical dimensions, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing damaged hip joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a femoral head component made of oxidized zirconium, designed to be part of a total hip replacement system. This is a physical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis. The device's function is mechanical replacement.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LZO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
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:
- . Pre-Fatigue and Post-Fatigue assembly and disassembly
- . Environmental Fatigue and Corrosion
- . Axial Fatigue
- . Range of Motion
- Device Rigidity, and .
- . Wear Performance
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.
Total Hip Femoral Head - 12/14 Taper (K021673), 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)
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
§ 888.3353 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.
0
Summary of Safety and Effectiveness 10/12 Taper Oxinium Femoral Heads Smith & Nephew, Inc.
APR 1 1 2011