K Number
K043406
Device Name
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
Manufacturer
Date Cleared
2005-07-15

(217 days)

Product Code
Regulation Number
888.3027
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Device Description
Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilization of the vertebral body and pain relief. Vertebroplastic™ Radiopaque Bone Cement has a low viscosity and long working and setting time
More Information

No
The description focuses on the material properties and intended use of a bone cement, with no mention of AI or ML capabilities.

Yes
The device is indicated for the treatment of pathological fractures of the vertebral body and provides stabilization and pain relief, which are therapeutic effects.

No

Explanation: This device is a bone cement used for treatment procedures (vertebroplasty/kyphoplasty) to fill defects and provide stabilization and pain relief. It does not perform any diagnostic function such as detecting, identifying, or analyzing medical conditions or disease markers.

No

The device description clearly states it is a "self-curing, radiopaque, polymethylmethacrylate (PMMA) cement," which is a physical material, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
  • Device Description and Intended Use: The description and intended use of Vertebroplastic™ Radiopaque Bone Cement clearly indicate it is a material used within the body during a surgical procedure (vertebroplasty or kyphoplasty) to fill and stabilize vertebral body defects. It is a physical implant/material, not a diagnostic test performed on a sample.

The device is a surgical material used for treatment, not for diagnosing a condition based on analyzing a biological sample.

N/A

Intended Use / Indications for Use

Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Product codes

NDN

Device Description

Vertebroplastic™ Radiopaque Bone Cement is a self-curing, radiopaque, polymethylmethacrylate (PMMA) cement, for filling of spinal vertebral body defects, in order to provide stabilization of the vertebral body and pain relief. Vertebroplastic™ Radiopaque Bone Cement has a low viscosity and long working and setting time

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

spinal vertebral body

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)

K041584, K032945, K002652, K873689

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

0

K043406

PREMARKET NOTIFICATION [510(k)] SUMMARY

Trade Name:Vertebroplastic™ Radiopaque Bone CementJUL 1 5 2005
Common Name:Polymethylmethacrylate (PMMA) bone cement
Classification Name:Filler bone cement (for vertebroplasty)
Regulatory Class:Class II, per 21 CFR §888.3027,
Device Code:NDN
510k Sponser:DePuy Spine, Inc.
325 Paramount Drive
Raynham, Massachusetts 02767-0350
Manufacturer:DePuy International Limited, trading as
DePuy CMW
Cornford Road
Blackpool
Lancashire FY4 4QQ
United Kingdom
Contact Person:Sharon Starowicz,
Director of Regulatory Affairs
DePuy Spine, Inc.
325 Paramount Drive
Raynham, Massachusetts 02767-0350
Tel.: (508) 828-2867; Fax: (508) 828-3797
Equivalent to:KyphX® HV-R™ Bone Cement Model C01A (K041584)
Stryker SpinePlex™ Radiopaque Bone Cement (K032945)
Stryker Howmedica Surgical Simplex® P Radiopaque pre-packed in
ACM and MixEvac II (K002652)
Cranioplastic™, acrylic cranioplasty material (K873689)
Device Description:Vertebroplastic™ Radiopaque Bone Cement is a self-curing,
radiopaque, polymethylmethacrylate (PMMA) cement, for filling of
spinal vertebral body defects, in order to provide stabilization of the
vertebral body and pain relief. Vertebroplastic™ Radiopaque Bone
Cement has a low viscosity and long working and setting time

1

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sharon Starowicz Director of Regulatory Affairs . DePuv Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350 JUL 1 5 2005

Re: K043406

Trade Name: Vertebroplastic Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Bone Cement for Vertebroplasty Regulatory Class: II Product Code: NDN Dated: June 8, 2005 Received: June 9, 2005

Dear Ms. Starowicz:

We have reviewed your Section 510(k) premarket notification of intent to market the device in diedicati We have reviewed your Section 910(x) promatice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regarry manation povice Amendments, or to commerce prof to May 26, 1776, the encenters with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of actived a devices that have been recuired in acceraaned while hall has aremarket approval application (PMA). and Cosment Act (Act) that to not require approval controls provisions of the Act. The You may, therefore, market the device, basject to the securements for annual registration, listing of general controls provisions of the Act moration requirement misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in can If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entroller of Color Sep. In addition, FDA may be found in the Code of Peachartergaming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuated on a badevice complies with other requirements of the Act that FDA has made a determination that your star formistered by other Federal agencies. You must of any Federal Statutes and regulations animations or system on and listing (21 comply with an the Act s requirements, mercums, can and acturing practice requirements as set

2

Page 2 - Sharon Starowicz

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. 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 (301) 443-6597 or at its Internet address .

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Vertebroplastic™ Radiopaque Bone Cement

Indications for Use:

Vertebroplastic™ Radiopaque Bone Cement is indicated for the treatment, using vertebroplasty or kyphoplasty procedures, of pathological fractures of the vertebral body caused by osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

Prescription Use × (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)

Evelin

(Division Sign-Off) Division of General, Restorative and Neurological Devices

51001, Monitor K043426

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