(139 days)
Not Found
No
The summary explicitly states that the modification is a change to the Instructions for Use and does not mention any AI or ML components.
Yes
The device, a hip replacement system, is used to treat medical conditions like osteoarthritis, rheumatoid arthritis, and femoral fractures, aiming to alleviate disability and correct functional deformities.
No
The device description indicates it is a joint replacement system used for total hip replacement or hemiarthroplasty applications, which is a therapeutic rather than a diagnostic function. The "Intended Use" also describes conditions that lead to the need for replacement, not conditions the device diagnoses.
No
The device description explicitly states the modification is a change to the Instructions for Use for existing hip replacement devices, which are hardware implants. The submission is focused on documentation changes for hardware, not a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for joint replacement, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a hip replacement system, which is a physical implant. The modification is to the Instructions for Use, not a change to a diagnostic test or reagent.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a condition, not to diagnose it.
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 Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemi-arthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications.
The following Hip Systems are for Cementless application:
Linear, Stamina, Foundation Press-Fit, Keystone Modular, Revelation, CLP Offset, CLP I, Foundation Fracture.
The following hip systems are for cemented application:
Foundation Cemented, Vitality.
The following hip systems are for either cementless applications:
CLP R, Alpha II, R120, R120PC.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LWJ, LZO, JDI, KWY, KWL, KWZ
Device Description
The modification consists of a change to the Instructions for Use for the devices listed 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)
Not Found
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.
K910010, K934169, K942611, K935449, K953510, K962560, K973302, K973614, K973685, K973809, K974093, K974095, K973119, K974294, K980473, K000521, K000817, K011774, K021822, K023794
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
Summary of Safety and Effectiveness
Date: April 18, 2007
Manufacturer: Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758
Contact Person: Teffany Hutto Regulatory Affairs Specialist Phone: (512) 834-6255 Fax: (512) 834-6313 Email: Teffany Hutto@encoremed.com
| Product | 510(k) Number, Clearance Date, Classification | Product Code |
|---|---|---|
| CLP I (Q System 28 Hip Stem) & CLP-R | K910010 – March 12, 1991 | |
| Class II | LWJ | |
| All Poly Acetabular Cup | K934169 – May 3, 1994 | |
| K942611 – September 28, 1994 | ||
| Class II | JDI | |
| Foundation Cemented Hip Stem | K935449 – March 30, 1995 | |
| Class II | JDI | |
| Bipolar | K953510 – August 9, 1995 | |
| Class II | KWY | |
| Vitality Hip Stem | K962560 – September 19, 1996 | |
| Class II | JDI | |
| Foundation Press-Fit Hip Stem & CoCr Femoral Heads | K973302 – December 2, 1997 | |
| Class II | LPH, LZO | |
| Unipolar with Modular Neck Length Sleeves | K973614 – December 18, 1997 | |
| Class II | KWI | |
| Revelation Hip Stem | K973685 – December 19, 1997 | |
| Class II | LPH | |
| Foundation Fracture Hip Stem | K973809 – January 2, 1998 | |
| Class II | LWJ | |
| FMP Acetabular Shells (Spiked, Hemispherical, and Flared) | K974093, K974095, and K973119 – | |
| January 28, 1998 | ||
| Class II | LPH | |
| Lincar Hip Stem | K974294 – January 12, 1998 | |
| Class II | LPH, LZO | |
| Stamina Hip Stem | K980473 – April 16, 1998 | |
| Class II | LZO, LWJ, KWY | |
| Keystone Modular Hip Stem | K000521 – May 10, 2000 | |
| Class II | LPH | |
| ALFA II (Omega II Modular Total Hip System) & Modular | ||
| Femoral Neck | K000817 – June 8, 2000 | |
| Class II | JDI, LPH | |
| R120 (R120 Modular Total Hip System) | K011774 – September 5, 2001 | |
| Class II | JDI, LPH | |
| R120 PC (R120 Modular Total Hip System) | K021822 – July 23, 2002 | |
| Class II | JDI, LPH | |
| FMP Constrained Acetabular Liners | K023794 – April 1, 2003 | |
| Class II | KWZ |
| Product Code | Regulation and Classification Name |
|---|---|
| LWJ | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR 888.3360 |
| JDI | Hip joint metal/polymer semi-constrained cemented prosthesis per 21 CFR 888.3350 |
| KWY | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis per 21 CFR 888.3390 |
| 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 21 CFR 888.3353 |
| KWL | Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis per 21 CFR 888.3360 |
| KWZ | Hip joint metal/polymer constrained cemented or uncemented prosthesis per 21 CFR 888.3310 |
1
Summary of Safety and Effectiveness - cont. Encore Medical - Hip System IFU
The modification consists of a change to the Instructions for Use for the devices Description: listed above to minimize the necessity for multiple IFU's and to update the contents to reflect current practice.
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 Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemi-arthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications.
The following Hip Systems are for Cementless application:
| Linear | Stamina |
|---|---|
| Foundation Press-Fit | CLP Offset |
| Keystone Modular | CLP I |
| Revelation | Foundation Fracture |
The following hip systems are for cemented application: Foundation Cemented Vitality
The following hip systems are for either cementless applications: CLP R Alpha II R120 PC R120
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same materials, design, indications, packaging, and sterilization.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2007
Encore Medical, L.P. % Ms. Teffany Hutto Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758
Re: K070050
Trade/Device Name: Encore Medical Hip System IFU 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, LWJ, LZO, JDI, KWY, KWL, KWZ Dated: April 18, 2007 Received: May 9, 2007
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 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.
3
Page 2 - Ms. Teffany Hutto
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
barbare Rouchup
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ___K070050
Device Name: Encore Medical Hip System IFU
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;
(Part 21 CFR 801 Subpart D)
- femoral fracture .
This device may also be indicated in the salvage of previously failed surgical attempts.
The Encore hip systems are for total hip replacement except for the bipolar or unipolar hip systems which are for hemiarthroplasty applications. The CLP Offset, CLP-R, and Stamina hip systems are for either total or hemi-applications.
| The following Hip Systems are for Cementless application: | |||
|---|---|---|---|
| Linear | Stamina | Keystone Modular | Revelation |
| Foundation Press-Fit | CLP Offset | CLP I | Foundation Fracture |
| The following hip systems are for cemented application: | |||
| Vitality | Foundation Cemented | ||
| The following hip systems are for either cemented or cementless applications: | |||
| Alpha II | CLP R | R120 | R120PC |
| Prescription Use | X | AND/OR | Over-The-Counter Use |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jubacebneupforma
Division Sign-Off
Restorative, and Neurological Devices
Page 1 of 1
(21 CFR 801 Subpart C)
(Posted November 13, 2003)
510(k) Number.