(77 days)
No
The device description focuses on the mechanical design and materials of a hip stem, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device, a Calcar Replacement Hip Stem, is intended for use in the treatment of various medical conditions, including fractures, non-union, erosion, and for revision hip arthroplasty, all of which fall under the scope of therapeutic intervention.
No
Explanation: The provided text describes a "Calcar Replacement Hip Stem" which is intended for the treatment of various hip and femoral conditions, and for revision hip arthroplasty. It is a device used in surgical procedures (implantation), not for diagnosing conditions.
No
The device description clearly details a physical hip stem implant made of materials and with features designed for surgical implantation, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various conditions of the hip and proximal femur. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components and features of a hip stem, which is a prosthetic implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Anatomical Site: The device is used within the body (hip joint, proximal femur), which is typical for a surgical implant, not an IVD.
- Intended User: The intended user is a surgeon, who performs surgical procedures, not laboratory personnel who typically use IVDs.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is an in vivo (within the body) implant used for treatment.
N/A
Intended Use / Indications for Use
The Calcar Replacement Hip Stem is intended for use in treatment of intertrochanteric, comminuted, or femoral neck fracture; trochanteric non-union; erosion of calcar or femoral neck, and; revision total hip arthroplasty involving bone loss in the proximal femur or tumors. In addition, the Calcar Replacement Hip Stem like the predicate IOI and competitive hip stems is intended for cemented application in cases of total hip arthroplasty.
-
- Patient conditions of intertrochanteric, comminuted or femoral neck fracture
-
- Trochanteric nonunion
-
- Erosion of the calcar or femoral neck
-
- Revision total hip arthroplasty involving bone loss in the proximal femur
-
- Tumors.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Calcar Replacement Hip Stem employs a Sulzer 12/14 configured threaded trunnion for attachment to the IOI's femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured threaded bore. The Biolox and Zirconia ceramic heads are available in two sizes, 28mm inner diameter (ID), and 32mm ID. The Biolox and ceramic bearing heads have been determined substantially equivalent by the FDA via 510(k) #'s K923934 and K942330.
The proximal body of the hip stem features an extraction hole in the anterior/posterior direction to facilitate removal of the hip stern if revision becomes necessary. The proximal body of the hip stem features a sloted flange which allows the surgeon the option of wiring the trochanter. The Calcar Replacement Hip Stem employs a keel below the proximal-medial flange for enhanced rotational stability.
The grit blasted distal portion of the hip stem employs two medial longitudinal grooves and is oval shaped. The grit blasted surfaces provide enhanced interdigitation with bone cement. The Calcar Replacement Hip Stem is available with a distal hole for optional use with the PMMA canal centralizer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, proximal femur
Indicated Patient Age Range
Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity.
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)
Not Found
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.
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.
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
K961727
510(k) Premarket Notification Summary of Safety and Effectiveness for Calcar Replacement Hip Stem
JUL 19 1996
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Calcar Replacement Hip Stem.
| Submitter: | Intermedics Orthopedics, Inc. (IOI)
9900 Spectrum Drive
Austin, Texas, 78717
Tel.: (512) 432-9900
Fax: (512) 432-9291 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Regarding this submission:
Name: Sam Mirza
Tel.: 512-432-9751
Fax: 512-432-9291 |
| | Official Correspondent
Name: Jacquelyn Hughes
Tel.: 512-432-9687
Fax.: 512-432-9291 |
| Date: | February 15, 1996 |
| Proprietary name | Natural Hip System
Calcar Replacement Hip Stem |
| Common Name: | Total Hip Prosthesis - Femoral Component |
| Classification name: | Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis (21CFR 888.3353). |
| Predicate Devices: | The features employed by Calcar Replacement Hip Stem are
substantially equivalent to the features employed by the following
predicate legally marketed devices:
- Calcar Replacement Stem: IΟΙ - (510(k) #K945516);
- Omnifit Head/Neck Hip Stem: Osteonics Corporation (510(k) No. unknown to IOI);
- HNR (Head and Neck Replacement) Stem:
Howmedica Corporation (510(k) No. K902712); and - Cemented Calcar Stem: Depuy Inc. (510(k) No. unknown to IOI); |
1
Device Description: The Calcar Replacement Hip Stem employs a Sulzer 12/14 configured threaded trunnion for attachment to the IOI's femoral heads, including Biolox and Zirconia ceramic heads, featuring a Sulzer 12/14 configured threaded bore. The Biolox and Zirconia ceramic heads are available in two sizes, 28mm inner diameter (ID), and 32mm ID. The Biolox and ceramic bearing heads have been determined substantially equivalent by the FDA via 510(k) #'s K923934 and K942330.
The proximal body of the hip stem features an extraction hole in the anterior/posterior direction to facilitate removal of the hip stern if revision becomes necessary. The proximal body of the hip stem features a sloted flange which allows the surgeon the option of wiring the trochanter. The Calcar Replacement Hip Stem employs a keel below the proximal-medial flange for enhanced rotational stability.
The grit blasted distal portion of the hip stem employs two medial longitudinal grooves and is oval shaped. The grit blasted surfaces provide enhanced interdigitation with bone cement. The Calcar Replacement Hip Stem is available with a distal hole for optional use with the PMMA canal centralizer.
Intended Use: The Calcar Replacement Hip Stem is intended for use in treatment of intertrochanteric, comminuted, or femoral neck fracture; trochanteric non-union; erosion of calcar or femoral neck, and; revision total hip arthroplasty involving bone loss in the proximal femur or tumors. In addition, the Calcar Replacement Hip Stem like the predicate IOI and competitive hip stems is intended for cemented application in cases of total hip arthroplasty.
-
- Patient conditions of intertrochanteric, comminuted or femoral neck fracture
-
- Trochanteric nonunion
-
- Erosion of the calcar or femoral neck
-
- Revision total hip arthroplasty involving bone loss in the proximal femur
-
- Tumors.
Patient selection will be largely dependent on patient's age, general health, conditions of available bone stock, any prior surgery and anticipated further surgeries. Prosthetic replacement is generally indicated only for patients who have reached skeletal maturity.
2
Summary of Technological Characteristics:
A side by side tabular comparison of the characteristics of the Calcar Replacement Hip Stem to those of the currently marketed IOI and competitive devices follows:
| Characteristics | Subject Device | Predicate Devices | ||
|---|---|---|---|---|
| Calcar | ||||
| Replacement | ||||
| HipStem | Calcar | |||
| Replacement | ||||
| Stem | Omnifit | |||
| Head/Neck | ||||
| Hip Stem | Head/Neck | |||
| Replacement | ||||
| System | ||||
| Manufacturer | Intermedics | |||
| Orthopedics, Inc. | Intermedics | |||
| Orthopedics, | ||||
| Inc. | Osteonics | |||
| Corporation | Howmedica | |||
| Inc. | ||||
| 510(k) No. | K945516 | K902712 | Unknown to | |
| IOI | ||||
| Intended Use | Cemented | Cemented | Cemented | Cemented |
| Material | Forged/Wrought | |||
| CoCr Alloy | Cast CoCr | |||
| Alloy | Cast | |||
| CoCr Alloy | CoCr Alloy | |||
| Slotted Flange | Yes | Yes | Yes | Yes |
| Extraction | ||||
| Hole | Yes | Yes | Yes | Yes |
| Collar | Yes | Yes | Yes | Yes |
| Proximal | ||||
| Medial Keel | Yes | Yes | Yes | Yes |
| Distal Hole | Yes | Yes | Yes | Yes |
| Stem length | 140 and 160 mm | 140 and 160 | ||
| mm | 120, 140, | |||
| 160, and | ||||
| 190 mm | 135, 165, | |||
| and 185mm |