(81 days)
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended to replace the anatomy of the femur in cases of total hip replacement, which is a therapeutic intervention.
No
Explanation: The device is a femoral hip stem intended to replace the anatomy of the femur in total hip replacement, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical implant (femoral hip stem) made of materials and with specific geometric features for surgical implantation. It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace the anatomy of the femur in total hip replacement. This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a physical implant designed for surgical insertion into the femur. It discusses materials, design features for fixation and stability, and how it connects to other components of a hip replacement. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a disease or condition
- Using reagents or test kits
The device is a surgical implant used for structural replacement, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Zweymueller SL Femoral Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the Zweymueller SL Femoral Hip Stem is intended to be intraoperatively assembled to the commercially available Sulzer Orthopedics Limited (SOL) or Intermedics Orthopedics, Inc. (IOI) femoral bearing heads.
The general indications associated with the use of Zweymueller SL
- 2. Fracture or avascular necrosis.
- Conditions consequent to earlier operations such as joint 3. reconstruction (Osteotomy), arthrodesis, hemi-arthroplasty, or total hip replacement (THP), total knee replacement, as well as operations on shoulder and elbow joints, and spinal surgery.
Product codes
888.3353
Device Description
The Zweymueller SL Femoral Hip Stem employs a Sulzer 12/14 configured trunnion for attachment to femoral heads, including Biolox ceramic heads, featuring a Sulzer 12/14 configured bore. The Biolox ceramic heads are available in two sizes (28mm and 32mm outer diameters (OD)).
The Zweymueller SL Femoral Hip Stem is a line extension of an existing legally marketed SOL's Zweymueller-SL Hip Prosthesis which has previously been determined substantially equivalent by the FDA via 510(k) #K871453. The Zweymueller SL Femoral Hip Stem is identical in design to the predicate Zweymueller-SL Hip Prosthesis except for the following:
- The Zweymueller SL Femoral Hip Stem is provided sterile; and
- The Zweymueller SL Femoral Hip Stem is available in sizes * 01 and 0 in addition to sizes 1 through 12.
The Zweymueller SL Femoral Hip Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. The proximal portion of the hip stem employs an extraction hole to facilitate removal of the stem in revision cases. The widened proximal geometry of the Zweymueller SL Femoral Hip Stem reduces stresses due to compressive and torsional forces by allowing forces to be transmitted over a larger area (Stress = Force/Area). The proximal/lateral portion of the hip stem employs four holes for optional use with a cerclage wire to provide enhanced fixation of the hip stem to the greater trochanter.
The entire stem below the neck of the hip stem is grit blasted to provide enhanced fixation in both cemented and cementless total hip arthroplasties. In a cemented application, the grit blasted surface provides greater cement interdigitation with bone cement. In a pressfit or cementless application, the grit blasted surfaces provide an enhanced bone/prosthesis interface.
The distal tip of the Zweymueller SL Femoral Hip Stem is of pyramidal shape and is rounded off at the transition to the shaft. This facilitates transmission of load to the distal cortical bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a series of four black shapes against a white background. The shapes are arranged horizontally, with the first shape appearing to be a cluster of strokes, followed by a single vertical stroke, a circular shape, and a rectangular shape. The shapes are solid and lack any internal details or textures.
510(k) Premarket Notification Summary of Safety and Effectiveness for Zweymueller SL Femoral Hip Stem
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the In accordance with also f ood 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Zweymueller SL Femoral 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: | May 24, 1996 |
| Proprietary name | Zweymueller SL Femoral Hip Stem |
| Common Name: | Hip Prosthesis |
| Classification name: | Hip joint metal/ceramic/polymer semi-constrained cemented
or
nonporous uncemented prosthesis (21CFR 888.3353). |
| Predicate Devices: | The features employed by the Zweymueller SL Femoral Hip Stem are
substantially equivalent to the features employed by the following
predicate legally marketed devices: |
| | Zweymueller-SL Hip Prosthesis, Sulzer Orthopedics Limited;
and
SL-Plus; Plus Endoprothetik. |
| Device Description: | The Zweymueller SL Femoral Hip Stem employs a Sulzer 12/14
configured trunnion for attachment to femoral heads, including Biolox
ceramic heads, featuring a Sulzer 12/14 configured bore. The Biolox
heads have been determined substantially equivalent by the FDA via |
1
510(k) number K892644. The Biolox ceramic heads are available in two sizes (28mm and 32mm outer diameters (OD)).
The Zweymueller SL Femoral Hip Stem is a line extension of an existing legally marketed SOL's Zweymueller-SL Hip Prosthesis which has previously been determined substantially equivalent by the FDA via 510(k) #K871453. The Zweymueller SL Femoral Hip Stem is identical in design to the predicate Zweymueller-SL Hip Prosthesis except for the following:
-
- The Zweymueller SL Femoral Hip Stem is provided sterile; and
- The Zweymueller SL Femoral Hip Stem is available in sizes * 01 and 0 in addition to sizes 1 through 12.
The Zweymueller SL Femoral Hip Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. The proximal portion of the hip stem employs an extraction hole to facilitate removal of the stem in revision cases. The widened proximal geometry of the Zweymueller SL Femoral Hip Stem reduces stresses due to compressive and torsional forces by allowing forces to be transmitted over a larger area (Stress = Force/Area). The proximal/lateral portion of the hip stem employs four holes for optional use with a cerclage wire to provide enhanced fixation of the hip stem to the greater trochanter.
The entire stem below the neck of the hip stem is grit blasted to provide enhanced fixation in both cemented and cementless total hip arthroplasties. In a cemented application, the grit blasted surface provides greater cement interdigitation with bone cement. In a pressfit or cementless application, the grit blasted surfaces provide an enhanced bone/prosthesis interface.
The distal tip of the Zweymueller SL Femoral Hip Stem is of pyramidal shape and is rounded off at the transition to the shaft. This facilitates transmission of load to the distal cortical bone.
The Zweymueller SL Femoral Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the Zweymueller SL Femoral Hip Stem is intended to be intraoperatively assembled to the commercially available Sulzer Orthopedics Limited (SOL) or Intermedics Orthopedics, Inc. (IOI) femoral bearing heads.
The general indications associated with the use of Zweymueller SL
Intended Use:
2
-
- Fracture or avascular necrosis.
- Conditions consequent to earlier operations such as joint 3. reconstruction (Osteotomy), arthrodesis, hemi-arthroplasty, or total hip replacement (THP), total knee replacement, as well as operations on shoulder and elbow joints, and spinal surgery.
Summary of Technological Characteristics:
A side by side tabular comparison of the characteristics of the Zweymueller SL Femoral Hip Stem to those of the currently marketed IOI and competitive devices follows:
| Characteristics | Subject Device
Zweymueller
SL Femoral
Hip Stem | Predicate Devices
Zweymueller-SL
Hip Prosthesis | SL-Plus |
|--------------------------------|---------------------------------------------------------|-------------------------------------------------------|------------------------|
| Manufacturer | Sulzer
Orthopedics
Limited | Sulzer
Orthopedics
Limited | Plus
Endoprothetik. |
| 510(k) No. | - | K871453 | K930963 |
| Application | Cementless | Cementless | Cementless |
| Material | Titanium Alloy | Titanium Alloy | Unknown to
IOI |
| Rectangular
cross-section | Yes | Yes | Yes |
| Holes on the
lateral side" | Yes | Yes | Yes |
| Pyramidal
shaped distal tip | Yes | Yes | Yes |
| Sizes | 01, 0, and
1-12 | 1 - 12 | Unknown to
IOI |