(77 days)
Preamendment H.B. Burch Anti-Protrusio Reinforcement cage: Sulzer Orthopedics Limited (Preamendment Status), Acetabular Roof Reinforcement Ring: Sulzer Orthopedics Limited (510(k) number K953578), Anti-Protrusio Reinforcement cage: Depuy Inc. (510(k) number unknown to IOI)
Not Found
No
The device description and intended use are for a mechanical implant (reinforcement cage) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is intended to bridge areas of acetabular bone loss, provide support for an acetabular implant, and address advanced joint destruction, among other medical conditions, indicating a direct role in patient treatment and rehabilitation.
No
The device is an orthopedic implant (a reinforcement cage for acetabular bone loss) and not a diagnostic tool. The "Diagnostic indications for use" section refers to conditions for which the device might be used, not that the device itself performs diagnostics.
No
The device description clearly states it is a physical implant made of stainless steel or titanium, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Burch/Schneider Reinforcement Cage is a physical implant made of metal (stainless steel or titanium) designed to be surgically placed within the body to support the acetabulum (hip socket).
- Intended Use: The intended use is to bridge bone loss and provide support for an acetabular implant within the body.
- Lack of Diagnostic Function: The device itself does not perform any tests on biological samples or provide diagnostic information in the way an IVD would. While it is used in patients with certain diagnostic conditions (like acetabular dysplasia or arthritis), the device's function is structural and supportive, not diagnostic.
The "Diagnostic indications for use" listed refer to the conditions for which the device might be used in a patient, not a diagnostic function of the device itself.
N/A
Intended Use / Indications for Use
The Burch/Schneider Reinforcement Cage is intended to bridge the areas of acetabular bone loss in patients with acetabular bone deficiency. In addition, the Burch/Schneider Reinforcement Cage, like the predicate devices, is intended to provide support for an all polyethylene acetabular implant in a cemented application.
Diagnostic indications for use of this device include, but are not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.
The general indications associated with the use of Burch/Schneider Reinforcement Cage in total hip arthroplasty include:
-
- Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis,
-
- Fracture or avascular necrosis of the femoral head,
-
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Burch/Schneider Reinforcement Cage is a modified version of the preamendment H.B. Burch Anti-Protrusio Reinforcement Cage, manufactured by Protek AG (now consolidated into Sulzer Orthopedics Limited), that has been in commercial distribution in the United States prior to 1976.
The Burch/Schneider Reinforcement Cage will be manufactured from either stainless steel (AISI 316L) or commercially pure (CP) Titanium (International Organization for Standards (ISO) 5832-2). The design of the Burch/Schneider Reinforcement Cage include the following:
- a dome area with a dome hole and screwholes.
- a superior flange employing screwholes for the optional attachment to the ilium.
- an inferior flange employing screwholes for the optional attachment to the ischium,
- available in thickness of 2.0 (+0.0. -0.3)mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabular
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)
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.
Preamendment H.B. Burch Anti-Protrusio Reinforcement cage: Sulzer Orthopedics Limited (Preamendment Status), Acetabular Roof Reinforcement Ring: Sulzer Orthopedics Limited (510(k) number K953578), Anti-Protrusio Reinforcement cage: Depuy Inc. (510(k) number unknown to IOI).
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
510(k) Premarket Notification Summary of Safety and Effectiveness for Burch/Schneider Reinforcement Cage
MAY - 3 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 Burch/Schneider Reinforcement Cage.
| Submitter: | Intermedics Orthopedics, Inc.
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 | Burch/Schneider Reinforcement Cage | | |
| Common Name: | Acetabular reinforcement cage | | |
| Classification name: | Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented
(21CFR 888.3350). Class 2 | | |
| Predicate Devices: | The features employed by Burch/Schneider Reinforcement Cage are substantially equivalent to the features employed by the following predicate legally marketed devices: | | |
| | ► Preamendment H.B. Burch Anti-Protrusio Reinforcement cage: Sulzer Orthopedics Limited (Preamendment Status) | | |
| | ► Acetabular Roof Reinforcement Ring: Sulzer Orthopedics Limited (510(k) number K953578) | | |
| | ► Anti-Protrusio Reinforcement cage: Depuy Inc. (510(k) number unknown to IOI). | | |
| Device Description: | The Burch/Schneider Reinforcement Cage is a modified version of the preamendment H.B. Burch Anti-Protrusio Reinforcement Cage, manufactured by Protek AG (now consolidated into Sulzer | | |
Burch/Schneider Reinforcement Cage Summary of Safety and Effectiveness Page SSE1
1
Orthopedics Limited), that has been in commercial distribution in the United States prior to 1976.
The Burch/Schneider Reinforcement Cage will be manufactured from either stainless steel (AISI 316L) or commercially pure (CP) Titanium (International Organization for Standards (ISO) 5832-2). The design of the Burch/Schneider Reinforcement Cage include the following:
- a dome area with a dome hole and screwholes. ♪
-
a superior flange employing screwholes for the optional attachment to the ilium.
- ♪ an inferior flange employing screwholes for the optional attachment to the ischium,
- ♪ available in thickness of 2.0 (+0.0. -0.3)mm
The Burch/Schneider Reinforcement Cage is intended to bridge Intended Use: the areas of acetabular bone loss in patients with acetabular bone In addition, the Burch/Schneider Reinforcement deficiency. Cage, like the predicate devices, is intended to provide support for an all polyethylene acetabular implant in a cemented application.
Diagnostic indications for use of this device include, but are not limited to, acetabular dysplasia, osteoporosis, protrusio acetabuli, cystic acetabular roof, reconstruction in cases of defects after fracture, acetabular loosening, tumors or revision surgery.
The general indications associated with the use of Burch/Schneider Reinforcement Cage in total hip arthroplasty include:
-
- Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis,
-
- Fracture or avascular necrosis of the femoral head,
-
- Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemi-arthroplasty and total hip replacement.
Summary of Technological Characteristics:
Substantial equivalence determination for the Burch/Schneider Reinforcement Cage is based upon the comparison of the subject device to the following legally marketed predicate Sulzer Orthopedics Limited and competitive devices:
- ♪ Preamendment H.B. Burch Anti-Protrusio Reinforcement Cage: Sulzer Orthopedics Limited (Preamendment Status)
2
- Acetabular Roof Reinforcement Ring: Sulzer Orthopedics ♪ Limited (510(k) number K953578)
- Anti-Protrusio Reinforcement cage: Depuy Inc. (510(k) ♪ number unknown to IOI)
The characteristics of the Burch/Schneider Reinforcement Cage, either alone or in combination, are substantially equivalent to the aforementioned predicate devices in terms of materials, intended use, and design characteristics. A side by side tabular comparison of the characteristics of the Burch/Schneider Reinforcement Cage to those of the predicate devices follows:
| Subject Device | Predicate Devices | |||
|---|---|---|---|---|
| Characteristics | Burch/Schneider | |||
| Reinforcement | ||||
| Cage | H.B. Burch | |||
| Anti-Protrusio | ||||
| Reinforcement | ||||
| Cage | Anti-Protrusio | |||
| Reinforcement | ||||
| Cage | Acetabular | |||
| Roof | ||||
| Reinforcement | ||||
| Ring | ||||
| Manufacturer | Sulzer | |||
| Orthopedics | ||||
| Limited | Sulzer | |||
| Orthopedics | ||||
| Limited | Depuy Inc. | Sulzer | ||
| Orthopedics | ||||
| Limited | ||||
| 510(k) No. | - | Preamendment | Unknown to IOI | K953578 |
| Application | Cemented | Cemented | Cemented | Cemented |
| Material | Stainless Steel or | |||
| CP Titanium | Stainless Steel | Stainless Steel | CP Titanium | |
| Superior Flange | Yes | Yes | Yes | No |
| Inferior Flange | Yes | Yes | Yes | No |
| Screwholes | Yes | Yes | Yes | Yes |
| Sterile | Yes | No | Unknown to IOI | Yes |
| Sizes | 44 and 50mm | |||
| Left/Right | 44 and 50mm | |||
| Left/Right | 44 and 50mm | |||
| Left/Right | Diameters 36 - | |||
| 58mm (2mm | ||||
| Increments) |
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