(65 days)
Not Found
No
The document describes a hip implant and its mechanical properties and indications for use. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, a joint replacement hip stem, is intended to treat conditions like osteoarthritis, avascular necrosis, and rheumatoid arthritis, which are diseases. Its purpose is to restore function and correct deformities for patients suffering from these conditions, aligning with the definition of a therapeutic device.
No
The device description indicates it is a joint replacement (hip stem) for orthopedic surgery, not a device used to diagnose medical conditions.
No
The device description clearly describes a physical implant (hip stem) made of materials and with specific geometric features, intended for surgical implantation. It also mentions non-clinical testing related to the physical properties of the device (fatigue, porous coating, ceramic burst). This is not a software-only device.
Based on the provided information, 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 this device is a joint replacement intended for surgical implantation in the hip joint to treat various conditions affecting the femoral head and proximal femur. It is a physical implant, not a test performed on a biological sample.
The information provided describes a medical device used in vivo (within the body) for surgical treatment, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis . of the natural femoral head
- rheumatoid arthritis
- correction of functional deformity
- femoral fracture .
This device may also be indicated in the salvage of previously failed surgical attempts.
The constrained acetabular component is indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuronuscular disease, or intra-operative instability and for who all other options to constrained acetabulati components have been considered.
The device is intended for cementless applications.
Product codes (comma separated list FDA assigned to the subject device)
LPH, MBL, LZO, KWZ
Device Description
This device has an asymmetrical body with an anterior build up that requires right and left components. When a symmetrical implant is used a large amount of cancellus bone often remains in the anterior metaphaseal portion of the femur. The anterior built en paovodes a more complete fill of the proximal femur. The proximal body is trapezoidal in cross-sectional geometry and tapers proximal to distal and lateral to medial. The distal stem portion is slightly conical in shape. The Revelation stem is collarless and has a Morse type taper to receive modular heads. The purpose of this application is to add an alternate porous coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head, femoral
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)
Non-Clinical Testing: Fatigue testing, Porous coating characterization, Ceramic burst assessment.
Clinical Testing: None provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
510(k) Summary
Date: October 2, 2012 -
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Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
NOV 2 2012
L
, TX 78758 .
Contact Person: Teffany Hutto Manger, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djoglobal.com
| Product | Classification | Product Codes | Product Code | Regulation and Classification Name |
|---|---|---|---|---|
| Revelation Porous Coated Hip Stem, Size 8 | Class II | LPH, MBL, LZO, KWZ | LPH | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR |
| 888.3358 | ||||
| MBL | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis per 21 CFR | |||
| 888.3358 | ||||
| LZO | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. | |||
| per 21 CFR 888.3353 | ||||
| KWZ | Hip joint metal/polymer constrained cemented or uncemented prosthesis per 21 CFR 888.3310 |
Description: This device has an asymmetrical body with an anterior build up that requires right and left components. When a symmetrical implant is used a large amount of cancellus bone often remains in the anterior metaphaseal portion of the femur. The anterior built en paovodes a more complete fill of the proximal femur. The proximal body is trapezoidal in cross-sectional geometry and tapers proximal to distal and lateral to medial. The distal stem portion is slightly conical in shape. The Revelation stem is collarless and has a Morse type taper to receive modular heads. The purpose of this application is to add an alternate porous coating.
Indications for Use:
Joint replacement is indicated for patients suffering from disability due to:
- non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis . of the natural femoral head
- rheumatoid arthritis ●
- correction of functional deformity ●
- femoral fracture .
This device may also be indicated in the salvage of previously failed surgical attempts.
The constrained acetabular component is indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuronuscular disease, or intra-operative instability and for who all other options to constrained acetabulati components have been considered.
The device is intended for cementless applications.
1
K122636 (pg. 2 of 2)
Predicate Device:
ಿ
DJO Surgical Revelation Hip Stem, Size 8 – K994070 DJO Surgical Revelation Hip Stem with P2 Coating – K081679
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same design features, materials, indications, sterilization, packaging and intended use.
Non-Clinical Testing: Fatigue testing, Porous coating characterization, Ceramic burst assessment.
Clinical Testing: None provided.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 2, 2012
Encore Medical, L.P. % Ms. Teffany Hutto Manager, Regulatory Affairs 9800 Metric Boulevard Austin, Texas 78758
Re: K122636
Trade/Device Name: Revelation Porous Coated Hip Stem, Size 8 Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, MBL, LZO, KWZ Dated: October 2, 2012
Received: October 3, 2012
Dear Ms. Hutto:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 – Ms. Teffany Hutto
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K122636
Device Name: Revelation® Porous Coated Hip Stem, Size 8
Indications for Use:
Revelation® Porous Coated Hip Stem, Size 8 Indications for Use
Joint replacement is indicated for patients suffering from disability due to:
- non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis . of the natural femoral head
- rheumatoid arthritis ●
- correction of functional deformity .
- femoral fracture .
This device may also be indicated in the salvage of previously failed surgical attempts
The constrained acetabular component is indicated for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for who all other options to constrained acetabular components have been considered.
The device is intended for cementless applications.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) (Division Sign-On)
Division of Surgical, Orthopedic.
Division of Surgical, Dovices Division or and Restorative Devices
510(k) Number .