NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE

K021336 · Novabone Products, LLC · MQV · Jul 25, 2002 · Orthopedic

Device Facts

• Record ID: K021336
• Device Name: NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
• Applicant: Novabone Products, LLC
• Product Code: MQV · Orthopedic
• Decision Date: Jul 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

NovaBone Resorbable Bone graft substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Device Story

NovaBone is a synthetic, resorbable, osteoconductive bone graft substitute composed of calcium phospho-silicate particles. Used by surgeons in clinical settings to fill non-structural bony voids or gaps in the extremities, spine, or pelvis. The material is packed into defect sites; it functions via ion diffusion and exchange with the in vivo environment, forming a calcium phosphate surface layer that acts as a scaffold for new bone ingrowth. As the material is progressively resorbed, it is replaced by host bone. It provides no mechanical strength and requires standard internal or external fixation for fracture stabilization. Benefits include promoting natural bone regeneration in non-load-bearing defects.

Clinical Evidence

No human clinical data provided. Evidence consists of side-by-side comparative in vivo animal studies: 1) Rabbit distal femur (6mm defect): NovaBone vs. Pro Osteon 500R; 2) Goat distal femur (10mm defect): NovaBone vs. Wright Plaster of Paris Pellets; 3) Sheep iliac crest: NovaBone vs. Wright Plaster of Paris Pellets. Results showed NovaBone supported bone regeneration and was resorbed and replaced by host bone in all models. Biomechanical properties were similar to predicates. No local or systemic adverse effects observed.

Technological Characteristics

Particulate calcium phospho-silicate material; thermally formed in a sodium silicate network. Biocompatible, non-antigenic. Osteoconductive scaffold. Sterilized via ETO. Meets ASTM F 1538-94 for trace element levels. Non-structural; requires fixation for load-bearing. Not software-based.

Indications for Use

Indicated for bony voids or gaps in the skeletal system (extremities, spine, pelvis) not intrinsic to structural stability. Applicable to surgically created osseous defects or traumatic bone injuries. Contraindicated for load-bearing defects without internal/external fixation.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

• Pro Osteon 500R (K980817)
• Wright Plaster of Paris Pellets (K963562)

Submission Summary (Full Text)

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510(k) Premarket Notification - 510(k) Summary NovaBone Products, LLC NovaBone® - Resorbable Bone Graft Substitute

JUL 2 5 2002

### 4/24/02 510(k) Summary NovaBone® - Resorbable Bone Graft Substitute

- Submitter Information: 1.

| Name: | NovaBone Products, LLC |
|------------|--------------------------------------------------|
| Address: | One Progress Boulevard, #33<br>Alachua, FL 32615 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | David M. Gaisser |

- 2. Name of Device:

| Trade Name: | NovaBone – Resorbable Bone Graft Substitute |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Osteoconductive Bone Void Filler<br>Synthetic Resorbable Bone Graft Material |
| Classification Name: | Unknown |

#### Legally Marketed Predicate Device: 3.

| Predicate #1: | Pro Osteon 500R [K980817] |
|---------------|-------------------------------------------|
| Predicate #2: | Wright Plaster of Paris Pellets [K963562] |

#### 4. Device Description

NovaBone® is a synthetic resorbable osteoconductive bone graft substitute particulate entirely composed of a calcium phospho-silicate material. The inorganic calcium and phosphorous components are thermally incorporated in a sodium silicate network designed specifically for its resorbability and osteoconductive nature. NovaBone is progressively resorbed and replaced by host bone during the healing process

- 5. Intended Use
NovaBone Resorbable Bone graft substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

NovaBone Products, LLC

1 Progress Blvd. Suite 33 Alachua, FL 32615 Tel: [phone] Fax: [phone]

Image /page/0/Picture/16 description: The image shows the logo for NovaBone Products. The logo is in black and white and features the words "NovaBone" in a stylized font, with a world map underneath. Below the world map, the word "Products" is written in a simple font. Above the logo, the number "K021336" is written.

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510(k) Premarket Notification - 510(k) Summary NovaBone Products, LLC NovaBone® - Resorbable Bone Graft Substitute

#### Technological Characteristics 6.

The technological characteristics of NovaBone, ProOsteon 500R, and Wright Plaster of Paris Pellets are similar, although not identical. NovaBone, ProOsteon 500R, and Wright Plaster of Paris Pellets are designed to be osteoconductive space-filling particulates to be gently packed into defect sites and to be used as a non-structural scaffold for the body's natural healing and bone regeneration process. To meet this design. NovaBone, ProOsteon 500R, and Wright Plaster of Paris Pellets are similar in nature; all three devices are particulate, synthetic, inorganic, biocompatible and osteoconductive materials.

The main technological characteristic difference between NovaBone , ProOsteon 500R, and Wright Plaster of Paris Pellets is their composition, each being composed of a different synthetic material. NovaBone is composed of Bioglass® (see description), ProOsteon 500R is composed of calcium carbonate with a thin calcium phosphate coating, and Wright Plaster of Paris Pellets is composed of calcium sulfate with stearic acid as a tableting aid. These different materials have different absorption rates. The Wright Plaster of Paris Pellets are absorbed between four and eight weeks, depending on the graft site, size and material used. NovaBone and ProOsteon 500R have a similar, slower absorption rate, but both are still substantially absorbed within the six-month timeframe normally associated with bone remodeling. For all three devices, bone forms throughout the graft site with the material being absorbed and replaced by new bone tissue.

The performance of NovaBone has been compared to ProOsteon 500R and to Wright Plaster of Paris Pellets in side-by-side comparison studies. Three such studies were conducted:

- A. A 6mm diameter defect in the distal femur of rabbits to compare NovaBone and ProOsteon 500R in the same animal. At three months, both materials showed similar residual graft material area, with a substantial reduction in NovaBone graft particulate area from initial post-implantation values. The graft site biomechanical properties were not statistically different between graft materials while new bone formation was greater for NovaBone than for the ProOsteon 500R.
- B. Comparisons between NovaBone and Wright Plaster of Paris Pellets were conducted in a goat femoral model. A 10mm diameter defect was created in the distal femur and evaluated at six weeks and six months. The Wright Plaster of Paris Pellets was mostly absorbed by six weeks, while some residual NovaBone was observed out to six months. The graft site biomechanical properties were similar between graft materials, with new bone formation greater for NovaBone than for the Wright Plaster of Paris Pellets.

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510(k) Premarket Notification - 510(k) Summary NovaBone Products, LLC NovaBone® - Resorbable Bone Graft Substitute

- C. Comparisons between NovaBone and Wright Plaster of Paris Pellets were also conducted in an iliac crest model in sheep. Unicortical defects were made and a channel was reamed in the cancellous space of the superior iliac crest. Both NovaBone and Wright Plaster of Paris Pellets showed better bone regeneration than empty control sites at six weeks and six months. Histologically, the NovaBone defects had greater amounts of new bone formation at six weeks.
- Warnings and Precautions 7.

NovaBone does not possess sufficient mechanical strength to support load bearing defects prior to soft and hard tissue ingrowth. In cases of fracture fixation, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes.

NovaBone is intended for use by surgeons familiar with bone grafting and internal/external fixation techniques. NovaBone must not be used to gain screw purchase or to stabilize screw placement.

- 8. Complications
Possible complications are the same as to be expected of autogenous bone grafting procedures. These may include: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, delayed union, loss of reduction, failure of fusion, loss of bone graft, graft protrusion and / or dislodgement, and general complications that may arise from anesthesia and / or surgery.

- 9. Conclusion
NovaBone is claimed to be substantially equivalent to ProOsteon 500R and Wright Plaster of Paris Pellets as a non-structural osteoconductive bone void filler for osseous defects. Side-by-side comparative in vivo performance data was presented, with no evidence of local or systemic adverse effects related to the device observed. Additional supporting in vitro and clinical data were supplied.

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| Substantial<br>Equivalence<br>Comparison | This Device<br>NovaBone | Predicate #1<br>Pro Osteon 500R<br>K980817 | Predicate #2<br>Wright Plaster of Paris<br>Pellets<br>K963562 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A non-structural<br>osteoconductive bone void<br>filler for osseous defects. | Same as new device | Same as new device |
| Indications | Bony voids or gaps of the<br>skeletal system (i.e., the<br>extremities, spine and pelvis) | Same as new device | Same as new device |
| Application | To be gently packed into<br>defect sites as a non-structural<br>scaffold for the body's natural<br>healing and bone regeneration<br>processes. | Same as new device | Same as new device |
| Material | Inorganic calcium phospho-<br>silicate, thermally formed and<br>bound together in a sodium<br>silicate network. | Inorganic calcium<br>carbonate core with a<br>thin, hydrothermally-<br>formed inorganic<br>calcium phosphate layer | Inorganic calcium<br>sulfate, pressed and<br>bound into pellets using<br>a stearic acid tableting<br>aid. |
| Device Action | Ion diffusion and ion exchange<br>occur between the NovaBone<br>particle surfaces and the in vivo<br>environment to form a calcium<br>phosphate surface layer. The<br>surface layer acts as a scaffold<br>for new bone formation<br>throughout the graft site via<br>osteoconduction. Continued<br>ion diffusion and exchange<br>results in material resorption. | The pre-existing<br>calcium phosphate layer<br>acts as a scaffold for<br>new bone formation and<br>ingrowth via<br>osteoconduction. The<br>calcium phosphate layer<br>is slowly resorbed to<br>expose the faster<br>resorbing calcium<br>carbonate core. | The pellets react with<br>bodily fluids to dissolve<br>to form calcium<br>phosphate mineral<br>deposits that act as a<br>scaffold for ingrowing<br>bone, the dissolved<br>calcium being<br>incorporated by new<br>bone tissue. |
| Performance | Bone infiltration occurs<br>throughout the graft site via<br>osteoconduction, resulting in<br>increased graft site mechanical<br>stiffness and strength | Same as new device | Same as new device. |
| Bone remodeling | New bone grows into the graft<br>area via osteconduction. The<br>material is slowly absorbed<br>and replaced by the host bone. | Same as new device | Same as new device. |
| Resorption Rate | Majority absorbed by six<br>months | Same as new device | Majority absorbed by<br>six to eight weeks |
| Substantial<br>Equivalence<br>Comparison | This Device<br>NovaBone | Predicate #1<br>Pro Osteon 500R<br>K980817 | Predicate #2<br>Wright Plaster of Paris<br>Pellets<br>K963562 |
| Biocompatibility | Biocompatible, non-antigenic | Same as new device | Same as new device |
| Mechanical | Particulate material; not<br>intended for use in load-<br>bearing defects without proper<br>internal or external fixation | Same as new device | Same as new device |
| Sterility | ETO | Gamma | Gamma |
| Voluntary<br>Standards met | Trace Element levels as cited<br>in ASTM F 1538--94,<br>"Standard Specification for<br>Glass and Glass Ceramic<br>Biomaterials for Implantation" | None known | None known |

# Table 3.1 Comparison of the New Device to the Marketed Predicate Devices

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Table 3.1 Comparison of the New Device to the Marketed Predicate Devices

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font. The text is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2002

Mr. David M. Gaisser Director of Operations NovaBone Products, LLC 1 Progress Boulevard. #33 Alachua, FL 32615

Re: K021336

NovaBone®- Resorbable Bone Graft Substitute Regulatory Class: unclassified Product Code: MQV Dated: April 24, 2002 Received: April 26, 2002

Dear Mr. Gaisser:

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 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). 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 requirements, as set forth in the Quality System Regulation (OS) 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 - Mr. David M. Gaisser

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K021336

Device Name: NovaBone - Resorbable Bone Graft Substitute

Indications For Use:

NovaBone Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). "These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) 1. Restorative

510(k) Number

Prescription Use

OR (Per 21 CFR 801.109)

Over-The-Counter Use