ORTHOPLAN

K974406 · Ortho-Graphics, Inc. · HWT · Feb 18, 1998 · Orthopedic

Device Facts

• Record ID: K974406
• Device Name: ORTHOPLAN
• Applicant: Ortho-Graphics, Inc.
• Product Code: HWT · Orthopedic
• Decision Date: Feb 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4800
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the OrthoPlan software, to overlay the constructed images to aid surgeons in their planning of orthopaedic surgeries.

Device Story

OrthoPlan is a software system for preoperative orthopaedic surgical planning. It accepts digitized x-ray images and digital representations of orthopaedic implants as input. The software constructs a composite image by overlaying implant templates onto the patient's x-ray data. Used by surgeons in a clinical setting on a personal computer, the system assists in visualizing implant placement and sizing. The output provides a visual aid for surgical planning, allowing surgeons to assess fit and positioning before the procedure, potentially improving surgical accuracy and patient outcomes.

Technological Characteristics

Software-based system for personal computers; functions by overlaying digitized implant templates onto digitized x-ray images.

Indications for Use

Indicated for orthopaedic surgeons planning surgical procedures using digitized x-rays and orthopaedic implant templates on a personal computer.

Regulatory Classification

Identification

A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

Ortho-Graphics, Inc.
Peter M. Stevens
President, CEO
100 North Medical Drive, Suite 4550
Salt Lake City, Utah 84113

May 14, 2024

Re: K974406
Trade/Device Name: OrthoPlan
Regulation Number: 21 CFR 888.4800
Regulation Name: Template for clinical use
Regulatory Class: Class I
Product Code: HWT

Dear Peter Stevens:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 18, 1998. Specifically, FDA is updating this SE Letter as an administrative correction. A second product code was inadvertently included.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Limin Sun, OHT6: Office of Orthopedic Devices, 301-796-7056, [e-mail].

Sincerely,

Limin Sun -S

Limin Sun, Ph.D.
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

FEB 18 1998

Peter M. Stevens, M.D.
President, CEO
Ortho-Graphics Inc.
100 North Medical Drive, Suite 4550
Salt Lake City, Utah 84113

Re: K974406
Trade Name: OrthoPlan
Regulatory Class: II
Product Codes: HWT and LNX
Dated: November 15, 1997
Received: November 21, 1997

Dear Dr. Stevens:

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 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 (Premarket Approval), 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 895. A 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 - Peter M. Stevens, M.D.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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): K974406

Device Name: OrthoPlan

Indications For Use:

The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the OrthoPlan software, to overlay the constructed images to aid surgeons in their planning of orthopaedic surgeries.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)Prescription Use ☑
OR Over-The-Counter Use ☐

(Per 21 CFR 801.109)

(Optional Format 1-2-96)


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