(157 days)
Not Found
No
The summary describes a mechanical hip stem with design modifications and material specifications. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a joint replacement (hip stem) indicated for patients suffering from disability due to various degenerative joint diseases and for the correction of functional deformity, which are therapeutic interventions.
No
Explanation: This device is a hip implant (femoral hip stem), which is a prosthetic device used for joint replacement, not a diagnostic tool. Its purpose is to correct functional deformity and replace damaged joints, not to identify or diagnose a condition.
No
The device description clearly states it is a femoral hip stem fabricated from wrought/forged Ti-6A1-4V with a porous coating, indicating it is a physical implantable device, not software.
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 joint replacement, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a femoral hip stem made of titanium, designed for surgical implantation. This is consistent with a medical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for diagnosis. IVDs are specifically designed for these purposes.
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 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.
This stem is to be press-fit. This stem is intended for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, KWZ
Device Description
The purpose of this application is to include a new line extension to the current Linear™ Porous Coated Hip Stem. The TaperFill Femoral Hip stem is designed with a reduced neck, shorter length, and increased proximal width as compared to the predicate Linear™ Hip Stem (K974294). The TaperFill™ stem has an equivalent or larger cross section area in all locations.
The TaperFill™ Femoral Hip Stem is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) to provide a porous surface.
There are no changes to materials, sterilization, packaging, or method of manufacture. The major dimensional changes are isolated below the calcar line, with TaperFill incorporating a larger anteriorposterior cross-sectional width and a reduced overall stem length. The critically stressed neck regions of the stem and the modular taper that mates with the existing modular heads are identical to the cleared Linear™ Hip Stem (K974294).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femoral Head, 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: Dimensional analysis, range of motion analysis
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.
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: June 20, 2013
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 | Classification | Product Code |
|---|---|---|
| TaperFill™ Femoral Hip Stem | Class II | LPH and LZO |
| Product Code | Regulation and Classification Name |
|---|---|
| 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 | |
| KWZ | Hip joint metal/polymer constrained cemented or uncemented prosthesis per 21 CFR 888.3310 |
Description:
The purpose of this application is to include a new line extension to the current Linear™ Porous Coated Hip Stem. The TaperFill Femoral Hip stem is designed with a reduced neck, shorter length, and increased proximal width as compared to the predicate Linear™ Hip Stem (K974294). The TaperFill™ stem has an equivalent or larger cross section area in all locations.
The TaperFill™ Femoral Hip Stem is fabricated from wrought/forged Ti-6A1-4V that conforms to ASTM F136. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) to provide a porous surface.
There are no changes to materials, sterilization, packaging, or method of manufacture. The major dimensional changes are isolated below the calcar line, with TaperFill incorporating a larger anteriorposterior cross-sectional width and a reduced overall stem length. The critically stressed neck regions of the stem and the modular taper that mates with the existing modular heads are identical to the cleared Linear™ Hip Stem (K974294).
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 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
JUN 2 1 2013
1
K130099
intra-operative instability and for who all other options to constrained acetabular components have been considered.
This stem is to be press-fit. This stem is intended for cementless use.
Predicate Device:
- Linear™ Porous Coated Hip Stem K974294 .
- P2 Coating on Linear Stem- K081679 .
- . P2 Coating on Linear Hip Stem Size 8 - K120241
Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications, materials, sterilization, packaging and intended use.
Non-Clinical Testing: Dimensional analysis, range of motion analysis
Clinical Testing: None provided
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side, and a stylized symbol on the right. The symbol features three angled shapes that resemble abstract human figures or flowing lines. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2013
Encore Medical, L.P. % Mr. William Garzon Regulatory Affairs Specialist 9800 Metric Boulevard Austin, Texas 78758
Re: K130099
Trade/Device Name: TaperFill™ Femoral Hip Stem 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, KWZ Dated: April 17, 2013 Received: April 23, 2013
Dear Mr. 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.
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 - Mr. William Garzon
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Anton E. Dmitriev
For Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): __K130099
Device Name: Taperfill™ Femoral Hip Stem
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 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.
This stem is to be press-fit. This stem is intended for cementless use.
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)
Elizabeth L. Frank -S
Division of Orthopedic Devices
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