(56 days)
No
The summary describes a hip replacement device and its components, focusing on materials and mechanical performance. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is a total hip replacement system, used to treat conditions like osteoarthritis and rheumatoid arthritis, which are considered therapeutic interventions to alleviate symptoms and restore function.
No.
The device is a hip replacement system, indicated for surgical repair of hip issues, not for diagnosis.
No
The device description clearly states it is a modification to a hip stem, which is a physical implant, and discusses mechanical testing. This indicates a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing the hip joint due to various conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a "ceramic femoral head with the hip stem," which are components of a hip replacement prosthesis.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
Total and partial hip replacement is indicated for patients suffering from disability due to:
- noninflammatory 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 Vitality and Keystone are designed for a cementless application while the Alfa II, R120, and R120PC are designed for either cemented or cementless applications.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI, LPH
Device Description
The modification consists of use of a ceramic femoral head with the hip stem. The material used in the Description: ceramic femoral head is the same as other legally marketed predicate devices.
. ne Vitality, Keystone, Alfa II, R120 and R120PC are all designed for total hip joint replacement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
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)
on-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing: None provided.
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.
K962560, K000521, K984227, K011774, K021822
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
§ 888.3353 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
| OCT 1 5 2008 | KO82398 #111
Summary of Safety and Effectiveness |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| | |
| No of Canada Comments of Children Comparison Comparison Comparison Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis | |
Date: September 22, 2008
Manufacturer: DJO Surgical (legally Encore Medical, L.P.) 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Manager, Regulatory Affairs Phone: (512) 834-6255 Fax: (512) 834-6313 Email: teffany.hutto@djosurgical.com
| Product | 510(k) Number, Clearance Date/
Classification | Product Code |
|---------------------------------------------|--------------------------------------------------|--------------|
| Vitality Hip Stem | K962560 - September 19, 1996 / Class II | JDI |
| Keystone Modular Hip Stem | K000521 - May 10, 2000 / Class II | LPH |
| ALFA II (Omega II Modular Total Hip System) | K984227 - November 24, 1998 / Class II | JDI |
| R120 (R120 Modular Total Hip System) | K011774 – September 5, 2001 / Class II | JDI |
| R120 PC (R120 Modular Total Hip System) | K021822 - July 23, 2002 / Class II | JDI |
| Product Code | Regulation and Classification Name |
|---|---|
| JDI | Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350 |
| LPH | 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 2 I CFR 888.3353 |
The modification consists of use of a ceramic femoral head with the hip stem. The material used in the Description: ceramic femoral head is the same as other legally marketed predicate devices.
. ne Vitality, Keystone, Alfa II, R120 and R120PC are all designed for total hip joint replacement.
Total and partial hip replacement is indicated for patients suffering from disability due to:
- . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis: .
- correction of functional deformity; �
- . femoral fracture
These devices may also be indicated in the salvage of previously failed surgical attempts.
The Vitality and Keystone are designed for a cementless application while the Alfa II, R120, and R120PC are designed for either cemented or cementless applications.
Intended Use: DJO Surgical hip devices are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use. While hip replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Predicate Device: Foundation Hip Stem - K955563
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications. materials, sterilization, and intended use.
on-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions.
Clinical Testing: None provided.
1
Image /page/1/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 symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
OCT 1 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Encore Medical, L.P. % Ms. Teffany Hutto Manager, Regulatory Affaris 9800 Metric Boulevard Austin, Texas 78758
Re: K082398
Trade/Device Name: Vitality, Keystone Modular, ALFA II, R120, R120PC Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, JDI, LPH Dated: September 22, 2008 Received: September 23, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set
2
Page 2 - Ms. Teffany Hutto
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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliation at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Vitality, Keystone Modular, Alfa II, R120, R120PC
Indications for Use:
Indications for Use
Total and partial hip replacement is indicated for patients suffering from disability due to:
- noninflammatory degenerative joint diseasc 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 Vitality and Keystone are designed for a cementless application while the Alfa II, R120, and R120PC are designed for either cemented or 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)
Nirf Rf Odl for axm
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number K082398
Page 1 of 1