510(k) · Cleared
ClearedIcon (TM) Modular Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 16, 2012 as substantially equivalent to K042514 (Blackstone Medical, Inc., 2004) and 4 other predicates after a 268-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Feb 16, 2012
- Review
- 268 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K980447 (1998). 34 ancestors in all, the oldest K933881 (1994). No later device cites it as a predicate yet.
- Root · 6 generations backK980447 Depuy Motech Moss Miami Spinal SystemDePuy Orthopaedics, Inc. · 1998
- 5 generations backK013558 Blackstone Spinal Fixation System 4.5MM Mono-Axial ScrewBlackstone Medical, Inc. · 2002
- 4 generations backK022399 Blackstone Spinal Fixation System SpacerBlackstone Medical, Inc. · 2002
- 3 generations backK030241 Modification to Blackstone Spinal Fixation SystemBlackstone Medical, Inc. · 2003
- 2 generations backK080407 Blackstone SFS Parallel Rod ConnectorsBlackstone Medical, Inc. · 2008 · Recalled
- 1 generation backK081684 Blackstone Pedicle Screw SystemBlackstone Medical, Inc. · 2008 · Recalled
- This deviceK111448 Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K980447 | Depuy Motech Moss Miami Spinal System | DePuy Orthopaedics, Inc. | 1998 | — |
| −5 | K013558 | Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw | Blackstone Medical, Inc. | 2002 | — |
| −4 | K022399 | Blackstone Spinal Fixation System Spacer | Blackstone Medical, Inc. | 2002 | — |
| −3 | K030241 | Modification to Blackstone Spinal Fixation System | Blackstone Medical, Inc. | 2003 | — |
| −2 | K080407 | Blackstone SFS Parallel Rod Connectors | Blackstone Medical, Inc. | 2008 | 1 |
| −1 | K081684 | Blackstone Pedicle Screw System | Blackstone Medical, Inc. | 2008 | 3 |
| 0 (this device) | K111448 | Icon (TM) Modular Pedicle Screw System | Orthofix, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042514 | Modification to Blackstone Modular Pedicle Screw SystemSummary page 1…0 Pedlicle Screw Spinal System Class Ill - NKB code Review Panel: Orthopedic Device Panel (87) Predicate Devices: K042514 - Blackstone Modular Pedicle Screw System, SE 10-7-04 K022623 - DePuy Moss M… | 2004 |
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 1…Orthopedic Device Panel (87) Predicate Devices: K042514 - Blackstone Modular Pedicle Screw System, SE 10-7-04 K022623 - DePuy Moss Miami Spinal System, SE 8-27-02 K031 585 - U&I Optima Spinal System, SE 6-27-03… | 2002 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…Modular Pedicle Screw System, SE 10-7-04 K022623 - DePuy Moss Miami Spinal System, SE 8-27-02 K031 585 - U&I Optima Spinal System, SE 6-27-03 K023498 - Blackstone STS System, SE 11-13-02… | 2003 |
| * | K023498 | Modification to Blackstone Spinal Fixation SystemSummary page 1…K022623 - DePuy Moss Miami Spinal System, SE 8-27-02 K031 585 - U&I Optima Spinal System, SE 6-27-03 K023498 - Blackstone STS System, SE 11-13-02 K081684 - Blackstone Firebird System, SE 9-15-08 Reason for 51 0(k)… | 2002 |
| * | K081684 | Blackstone Pedicle Screw SystemSummary page 1…8-27-02 K031 585 - U&I Optima Spinal System, SE 6-27-03 K023498 - Blackstone STS System, SE 11-13-02 K081684 - Blackstone Firebird System, SE 9-15-08 Reason for 51 0(k) Submission: Modifications to the ICON System Orthofi… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 6 of the 34 ancestors have a recall of any class.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The ICON TM Modular Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedlicle fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft bone. The device is indicated for all of the following indications: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies, 2.…
Read the full statement (122 words)
The ICON TM Modular Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. Pedlicle fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft bone. The device is indicated for all of the following indications:
1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies,
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation),
4. Spinal stenosis
5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor,
7. Pseudoarthrosis, and
8. Failed previous fusion
The ICON TM Modular Spinal Fixation System components may be used with certain components of the Orthofix SF5 system, including rods, rod connectors and cross-connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111448 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111448: Icon (TM) Modular Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111448
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026