(27 days)
The ACTERA™ hip system may be designed from a patient's preoperative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the ACTERA™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
- A severely painful and/or disabled joint from osteoarthrits, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
- Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The ACTERA™ hip system implants are intended for cementless fixation using an anterior, lateral or posterior surgical technique.
The ACTERA™ hip system is an uncemented, primary total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. Optional Surgical plans (iViews) and iJgs/ancillary instruments are also available. Non-sterile reusable instruments are provided.
The subject ACTERA™ is comprised of the subject Actera™ femoral stem (cleared in K221104) with additional sizes (0, 1 and 10, 11, 12) added to the size portfolio. Additionally, the subject ACTERA™ will offer a patient specific neck option. This option has the same stem body (K221104) with a patient specific neck (K192198). The patient specific neck has the same neck version angle, and similar neck length as that cleared in the secondary predicate Conformis Hip System (K192198). The subject hip stems with patient specific necks are compatible with the same femoral heads and acetabular components as the patient specific necks cleared in the Conformis Hip System (K192198). The ACTERA™ with the patient-specific neck option will be ordered as 'ACTERA™ HipRx'.
This submission also seeks clearance of iJigs®/Ancillary Instruments to assist in the positioning of the ACTERA™ implants. The iligs® are sterile, single-use disposable instruments of nylon material. These instruments may be standardized or patient specific. These instruments are the iJig instrumentation described in the secondary predicate K192198 (and K202484). These instruments were not offered with the initial release of the ACTERA™ device, primary predicate Actera™ K221104. Additionally, Surgical Plans, called iViews, are also part of this submission. The iligs and iViews are provided based on ordered options.
The stem taper is identical to the predicates. The subject device, ACTERA™ is compatible with the previously cleared femoral heads (Ceramic or CoCrMo) and acetabular components. The femoral head is unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). The Cordera acetabular cup, Cordera cup liner and Cordera screws are unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). There are no changes with this these components and are not the subject of this submission.
The provided text is a summary for a 510(k) premarket notification of the ACTERA™ hip system. It does not describe a study involving an AI medical device or digital health software, nor does it present specific acceptance criteria with quantifiable performance metrics.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document focuses on the substantial equivalence of new components (extended sizes for the femoral stem, patient-specific neck option, iJigs, and surgical plans) to previously cleared predicate devices, supported by non-clinical performance evaluations like fatigue testing of the physical implants.
§ 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.