(76 days)
Not Found
No
The device description explicitly states the modification is a change to the Instructions for Use, and there are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device, a joint replacement, is intended to treat and alleviate various degenerative joint conditions, thereby fitting the definition of a therapeutic device.
No
Explanation: The "Intended Use/Indications for Use" section describes the conditions for which joint replacement is indicated, such as osteoarthritis or femoral fracture. This device acts as a treatment (joint replacement), not to diagnose these conditions. The description also mentions the device is a "modification...to the Instructions for Use," implying a surgical implant rather than a diagnostic tool.
No
The device description explicitly states the modification is to the Instructions for Use of a hip stem, which is a physical implant. The summary does not describe any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for joint replacement, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description focuses on a modification to the Instructions for Use for a hip stem, which is a physical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to diagnose diseases or conditions in vitro (outside the body).
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Joint 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 following Hip Stems are for Cementless application:
Linear Porous Coated Hip Stem, Size 5
Revelation Hip Stem, Size 8
Foundation Porous Press Fit Stem, Size 8
The following Hip Stems are for Cemented application: Foundation Cemented Hip Stem, Size 10.5 - 18 Foundation Cemented Stem, Size 8 Foundation Cemented Stem, Size 9
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, JDI, JDG
Device Description
The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
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)
Non-Clinical Testing: None Provided
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.
K991325, K994070, K991226, K952191, K991227, K961890
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
K12/024
JUN 1 9 2012
Summary of Safety and Effectiveness
Date: March 23, 2012
Manufacturer: Encore Medical, L.P. Trade Name: DJO Surgical 9800 Metric Blvd Austin, TX 78758
Contact Person: William Garzon Regulatory Affairs Specialist Phone: (512) 834-6391 Fax: (512) 834-6313 Email: william.garzon@djoglobal.com
| Product | 510(k) Number, Clearance Date /
Classification | Product
Code | Classification Name |
|-------------------------------------------------|---------------------------------------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| Linear Porous Coated Hip
Stem, Size 5 | K991325 - June 25, 1999, Class
II | LPH | Hip joint metal/polymer/metal semi-
constrained porous coated uncemented
prosthesis per 21 CFR 888.3358 |
| Revelation Hip Stem, Size
8 | K994070 - January 20, 2000,
Class II | LPH | Hip joint metal/polymer/metal semi-
constrained porous coated uncemented
prosthesis per 21 CFR 888.3358 |
| Foundation Porous Press
Fit Stem, Size 8 | K991226 - June 1, 1999, Class
II | LZO | Hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous
uncemented prosthesis per 21 CFR 888.3353 |
| Foundation Cemented Hip
Stem, Size 10.5 - 18 | K952191 - July 17, 1995, Class
II | JDI,
JDG | Hip joint metal/polymer semi-constrained
cemented prosthesis per 21 CFR 888.3350 |
| Foundation Cemented
Stem, Size 8 | K991227 - June 1, 1999, Class
II | JDI | Hip joint metal/polymer semi-constrained
cemented prosthesis per 21 CFR 888.3350 |
| Foundation Cemented
Stem, Size 9 | K961890 - June 14, 1996, Class
II | JDI | Hip joint metal/polymer semi-constrained
cemented prosthesis per 21 CFR 888.3350 |
Description: The modification consists of a change to the Instructions for Use to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
Indications for Use: Joint 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 following Hip Stems are for Cementless application:
Linear Porous Coated Hip Stem, Size 5
Revelation Hip Stem, Size 8
Foundation Porous Press Fit Stem, Size 8
1
K12/024 Page 2/2
Summary of Safety and Effectiveness - cont. DJO Surgical Hip Systems
The following Hip Stems are for Cemented application: Foundation Cemented Hip Stem, Size 10.5 - 18 Foundation Cemented Stem, Size 8 Foundation Cemented Stem, Size 9
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications, sterilization, and intended use.
Non-Clinical Testing: None Provided
Clinical Testing: None provided
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Encore Medical, L.P. % Mr. William Garzon Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758
JUN 1 9 2012
Re: K121024
Trade/Device Name: Linear Porous Coated Hip Stem, Size 5
Revelation Hip Stem, Size 8 Foundation Porous Press Fit Stem, Size 8 Foundation Cemented Hip Stem, Size 10.5 - 18 Foundation Cemented Stem, Size 8 Foundation Cemented Stem, Size 9
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, LZO, JDI, JDG Dated: March 27, 2012 Received: April 04, 2012
Dear Mr. William Garzon:
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.
3
Page 2 -- Mr. William Garzon
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 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.
Mark N. Mel
Sincerely yours,
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1/6
Device Name: Linear Porous Coated Hip Stem, Size 5
Indications for Use:
Linear Porous Coated Hip Stem, Size 5 Indications for Use
Joint 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. This stem is intended to be used in a cementless mode.
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)
Ast
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121024
5
Page 2/6
Device Name: Revelation Hip Stem, Size 8
Indications for Use:
Revelation Hip Stem, Size 8 Indications for Use
Joint 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. This stem is intended to be used in a cementless mode.
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)
Asit
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
KIZIOLY
510(k) Number
6
Page 3/6
Device Name: Foundation Porous Press Fit Stem, Size 8
Indications for Use:
Foundation Porous Press Fit Stem. Size 8 Indications for Use
Joint 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. This stem is intended to be used in a cementless mode.
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)
Ashf
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
×121024 510(k) Number
7
Page 4/6
Device Name: Foundation Cemented Hip Stem, Size 10.5 - 18
Indications for Use:
Foundation Cemented Hip Stem, Size 10.5 - 18 Indications for Use
Joint 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. This stem is intended to be used in a cemented mode.
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)
Arsh
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
KILIO24 510(k) Number .
8
Page 5/6
Device Name: Foundation Cemented Stem, Size 8
Indications for Use:
Foundation Cemented Stem, Size 8 Indications for Use
Joint 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. This stem is intended to be used in a cemented mode.
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)
ASnt
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
K 121024 510(k) Number
9
Oze 6/6
Device Name: Foundation Cemented Stem, Size 9
Indications for Use:
Foundation Cemented Stem, Size 9 Indications for Use
Joint 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. This stem is intended to be used in a cemented mode.
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)
A
(Division Sign-Oft) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K|z|ozy