(87 days)
Not Found
No
The summary describes a purely mechanical implant for hip reconstruction and contains no mention of AI or ML.
Yes
The device is used to reconstruct the acetabulum in total hip arthroplasty, specifically to reinforce a deficient or weakened medial wall, which directly addresses a pathological condition (deficient/weakened bone) and restores function (stable fixation of the acetabular component).
No
The device is described as a surgical implant used for reconstruction, not for identifying or diagnosing a condition.
No
The device description clearly states it is a "hemi-spherical, metal shell" with "flanges and screw holes," indicating it is a physical hardware implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Kerboull Cross is a physical, implantable device (a metal shell) used to reconstruct the acetabulum during hip surgery. It is used in vivo (within the living body) to provide structural support.
The information provided describes a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Kerboull Cross is intended to be used to reconstruct the acetabulum in primary and/or revision total hip arthroplasty. Specifically, this device is used to reinforce the medial wall of the acetabulum to achieve stable fixation of the acetabular component in the presence of a deficient or weakened medial wall caused by severe inflammatory disease, fracture of the medial wall, or failed total hip arthroplasty.
Product codes
JDJ
Device Description
The Kerboull Cross is a hemi-spherical, metal shell that incorporates several flanges and screw holes and is shaped to fit into the acetabulum. These devices are available in a range a outer diameters to fit varying anatomical requirements. This device will be manufactured in three materials; Stainless Steel, Vitallium, and Titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
acetabulum
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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) Summary
Proprietary Name: Kerboull Cross
Common Name: Acetabular Reinforcement Shell
Classification Name and Reference: Prosthesis, Hip, Acetabular Mesh 21 CFR 878.3300
NOV - 3 1997
Proposed Regulatory Class: Class II Device Product Code: OR(79) JDJ
For information contact:
Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 8-8-97
The Kerboull Cross is intended to be used to reconstruct the acetabulum in primary and/or revision total hip arthroplasty. Specifically, this device is used to reinforce the medial wall of the acetabulum to achieve stable fixation of the acetabular component in the presence of a deficient or weakened medial wall caused by severe inflammatory disease, fracture of the medial wall, or failed total hip arthroplasty.
This device will be manufactured in three materials; Stainless Steel, Vitallium, and Titanium alloy.
The Kerboull Cross is a hemi-spherical, metal shell that incorporates several flanges and screw holes and is shaped to fit into the acetabulum. These devices are available in a range a outer diameters to fit varying anatomical requirements.
The substantial equivalence of the Kerboull Cross is based on an equivalence in intended use, materials, design, and relative indications and contraindications to Depuy's Protrusio Cage (K962007).
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1997
Mr. Frank Maas Manager, Regulatory Affairs Howmedica Incorporated Pfizer Medical Technology Group 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
Re: K972928 Kerboulli Cross Acetabular Reinforcement Shell Requlatory Class: İI Product Code: JDI Dated: August 8, 1997 Received: August 8, 1997
Dear Mr. Maas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Frank Maas
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
Ph.D., M.D. Cella M. Witten, Director Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K972928
Device Name: Kerboull Cross
Indications for Use:
The Kerboull Cross is intended to be used to reconstruct the acetabulum in primary and/or revision total hip arthroplasty. Specifically, this device is used to reinforce the medial wall of the acetabulum to achieve stable fixation of the acetabular component in the presence of a deficient or weakened medial wall caused by severe inflammatory disease, fracture of the medial wail, or failed total hip arthroplasty.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR | Over-The-Counter Use |
(Division Sign-Off) (Optional Format 1-2-96)
Division of General Restorative Devices
| 510(k) Number | K972928 |
|---|---|
| --------------- | --------- |
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