(67 days)
The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is to be press-fit.
When viewed in the mediolateral plane the Linear™ Porous Coated Hip Stem tapers slightly proximal to distal beginning at the distal border of the porous coating. Proximal to this point the stem flares approximately 6°. The stem has a rectangular cross-sectional geometry to provide rotational stability. The Linear™ Porous Coated Hip Stem is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136 or F620, respectively. The outside surface of the stern is porous coated with commercially pure titanium (ASTM F67 grade 2) to provide a porous surface for enhanced fixation. The stem is intended to be press-fit. The Linear™ Porous Coated Hip Stem is collarless and has a Morse type taper to receive modular heads. This stem is available with a standard head/stem offset and a lateralized version that provides additional lateralization of the patient's femur without increasing leg length. The stem/neck angle is 135°.
The provided text describes a medical device, the Linear™ Porous Coated Hip Stem, and its regulatory approval (K991325). It details the device's characteristics, materials, and intended use. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
Instead, the document focuses on:
- Device Description: Physical attributes, materials, and manufacturing standards.
- Intended Use/Indications For Use: Clinical conditions for which the device is designed to be used.
- Comparable Features to Predicate Device(s): How it is similar to previously approved devices.
- Test Results (Limited): It mentions "Finite element analysis of the fatigue stem strength and laboratory testing of the Morse type taper was conducted," but provides no specific results, acceptance criteria for these tests, or detailed methodology.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary data is not present in the provided text.
Here's how I would answer based on the absence of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | Not specified in the provided text |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document mentions "Finite element analysis" and "laboratory testing," but no sample sizes for these tests are provided.
- Data provenance: Not applicable, as there are no detailed test results or clinical data presented to determine provenance (e.g., country of origin, retrospective/prospective). The tests mentioned appear to be mechanical/simulation-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes a hip stem, a physical implant. The "ground truth" concept (e.g., for diagnostic algorithms) does not apply here. The "tests" mentioned are mechanical stress analysis and taper quality, which would have engineering standards as their basis, not expert consensus on interpretations.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is mentioned or relevant for the types of tests alluded to (finite element analysis, lab testing of taper).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a hip implant, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study and AI performance metrics are not relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hip implant, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of diagnostic AI. For the mechanical tests mentioned, the "ground truth" would be established engineering standards and physical properties of the materials and design, against which the results of the finite element analysis and laboratory testing would be compared. These standards are not detailed.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical medical device.
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Encore Orthopedics®. Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500
Trade Name: Linear™ Porous Coated Hip Stem
Common Name: Cementless hip stem
Classification Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis
Description
When viewed in the mediolateral plane the Linear™ Porous Coated Hip Stem tapers slightly proximal to distal beginning at the distal border of the porous coating. Proximal to this point the stem flares approximately 6°. The stem has a rectangular cross-sectional geometry to provide rotational stability
The Linear™ Porous Coated Hip Stem is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136 or F620, respectively. The outside surface of the stern is porous coated with commercially pure titanium (ASTM F67 grade 2) to provide a porous surface for enhanced fixation. The stem is intended to be press-fit.
The Linear™ Porous Coated Hip Stem is collarless and has a Morse type taper to receive modular heads. This stem is available with a standard head/stem offset and a lateralized version that provides additional lateralization of the patient's femur without increasing leg length. The stem/neck angle is 135°.
Intended Use: The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is to be press-fit.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include Ti-6Al-4V substrate, straight stem, symmetric, no collar, narrow slightly taper stem in lateral view, and modular heads.
Test Results: Finite element analysis of the fatigue stem strength and laboratory testing of the Morse type taper was conducted.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 1999
Ms. Debbie De Los Santos Requlatory/Clinical Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758
Re: K991325 Linear™ Porous Coated Hip Stem - Size 5 Trade Name: Regulatory Class: II Product Codes: LPH and LZO Dated: April 16, 1999 Received: April 19, 1999
Dear Ms. De Los Santos:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Debbie De Los Santos
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): __
Device Name: __ Linear™ Porous Coated Hip Stem_
Indications For Use:
Linear™ Porous Coated Hip Stem Indications For Use
The indications for use of the total hip replacement prosthesis include: noninflammatory I he midications for alle or allo to and the interest and avascular necrosis; theumatoid arthritis; correction of functional deformity, revision procedures where other treatments or devices have colronon of rancelonal coronial) fenoral neck and trochanteric fractures of the proximal femur with head involvement, which is umanageable using other techniques. This stem is to be pressfit.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)_
Division Sign Off
(Division of General Restor 5 IUlia) Number
.
§ 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.