(21 days)
N/A
No
The summary describes a mechanical implant for hip reconstruction and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is an implant for reconstructing the hip joint, providing structural integrity to a compromised joint, which falls under the category of a medical device used for treatment, but not a therapeutic device in terms of delivering a therapy (e.g., electrical, heat, light).
No
Explanation: The device description clearly states "The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, deformity or trauma." and "These cages...provide structural integrity to an otherwise structurally compromised joint." This indicates a reconstructive, therapeutic purpose, not a diagnostic one. There is no mention of analysis, detection, or diagnosis of conditions.
No
The device description explicitly states the device is manufactured from Titanium and is a physical implant intended for surgical use, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reconstruction of the hip joint due to disease, deformity, or trauma. This is a surgical implant used in the body, not a test performed on samples taken from the body.
- Device Description: The device is described as a titanium implant with flanges and screw fixation holes, designed to provide structural integrity to the hip joint. This is a physical device for implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a therapeutic implant used to physically repair a damaged joint.
N/A
Intended Use / Indications for Use
The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, deformity or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. The Protrusio Cage is to be used in conjunction with any commercially available polyethylene acetabular cup.
Product codes (comma separated list FDA assigned to the subject device)
JDI
Device Description
This series of six anatomic protrusio cages is manufactured from Titanium. Each cage has two illac flanges positioned superiorly and one ischial flange positioned inferiorly that provide supplemental screw fixation holes for attachment to the ilium. These cages, once positioned in the acetabulum and attached to the ilium and ischium, provide structural integrity to an otherwise structurally compromised joint.
The device is a single use implant intended for implantation with bone cement.
In cases where bony defects or voids exist, optional augments can be utilized to help provide additional structural support. The augments are attached to the cage by means of a locking screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint / acetabulum / ilium / ischium
Indicated Patient Age Range
skeletally mature individuals
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)
Non-Clinical Testing: Testing determined that Patriot Protrusio Cage components presented no new risks and were: therefore, substantially equivalent to the predicate device.
Clinical Testing: None provided as a basis for substantial equivalence.
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.
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
JAN 3 0 2002
K020076
page 1 of 1
ARTERS CORPORATE
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor:
Biomet. Inc. 56 East Bell Drive P.O. Box 587 Warsaw, In. 46581-0587
Contact Person:
Tracy Bickel (219) 267-6639
Proprietary Name:
Common Name:
Acetabular Component
Patroit Protrusio Cage
Classification Name:
Hip joint metal/polymer/metal semi-constrained uncemented prosthesis (888.3358)
Patriot Protrusio Cage - K001376 Substantially Equivalent Devices:
This series of six anatomic protrusio cages is manufactured from Titanium. Each cage Device Description: has two illac flanges positioned superiorly and one ischial flange positioned inferiorly that provide supplemental screw fixation holes for attachment to the ilium. These cages, once positioned in the acetabulum and attached to the ilium and ischium, provide structural integrity to an otherwise structurally compromised joint.
The device is a single use implant intended for implantation with bone cement.
In cases where bony defects or voids exist, optional augments can be utilized to help provide additional structural support. The augments are attached to the cage by means of a locking screw.
Intended use: The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, deformity or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. The Protrusio Cage is to be used in conjunction with any commercially available polyethylene acetabular cup.
The Patriot Protrusio Cage material, design, sizing, and indications are similar Summary of Technologies: to or identical to the predicate devices.
Non-Clinical Testing: Testing determined that Patriot Protrusio Cage components presented no new risks and were: therefore, substantially equivalent to the predicate device.
Clinical Testing: None provided as a basis for substantial equivalence.
All Trademarks are property of Biomet, Inc.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
1
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL רחוגet@biomet.corret.corret.co
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
K020076 Re:
Trade Name: Patriot Protrusio Cage Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/ metal semiporous-coated uncemented prosthesis Regulatory Class: II Product Code: JDI Dated: January 7, 2002 Received: January 9, 2002
Dear Ms. Bickel:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of re(i) prother is substantially equivalent (for the relerenced above and we have decembliod the evices marketed in interstate commerce prior to indications for use stact in the energian of the Medical Device Amendments, or to devices that have May 26, 1970, the chaculten date of the Frederal Food, Drug, and Cosmetic Act
been reclassified in accordance with the provisions of the Federal Food, Drug, March Way been recrassified in accordance will a premarket approval application (PMA). You may, (Act) that do not require approval of to the general controls provisions of the Act. The general therefore, market the device, subject to the generals for annual registration, listing of devices. controls provisions of the rice merace sont prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0070) als. Existing major regulations affecting your device can may be subject to such additional controller "Little 21, Parts 800 to 898. In addition, FDA may oc found in the Souv acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease oc advised that I DTT 3 ibsunted or our device complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of any I catales and regarations and regarations and limited to: registration and listing (21 Comply with an the Aot 8 requirements, only, good manufacturing practice requirements as set CI K Fat 807), adomig (21 OFR Part 820); and if applicable, the electronic forth in the quality 35sems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Tracy J. Bickel
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in yourse ough finding of substantial equivalence of your device to a legally promaticated predicated for 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 regulation (21 CFR Part 801 and 11 you desire specific ad 100 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 0071. Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1697 Fridae of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oinor general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark N. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page _ of _
510(k) Number (if known): __ ko2 0276 Device Name: Patriot Protrusio Cages Indications for Use:
The Protrusio implants are intended for use in reconstruction of the hip joint due to disease, The Frounds in plants are intended for general use in skeletally mature individuals.
deformity or trauma. The devices are intended for general use in a mass implant undergoing primary and/or secondary revision surgery. The device is a single lise implant. undergoting primary and/or socondary revision with any commercially available polyethylene acetabular cup.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✗
OR
(Per 21 CFR 801,109)
for
Mark A. Melhern
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K020076
Over-The-Counter Use (Optional Format 1-2-96)
0007b