510(k) · Cleared
ClearedOLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 21, 2025 as substantially equivalent to K231694 (Astura Medical, 2023) and 3 other predicates after an 85-day review. Its family tree reaches back 20 generations to 2004. 1 of the 607 devices in its family, counting itself, has a Class I recall.
- Decided
- Oct 21, 2025
- Review
- 85 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 20 generations to K040583 (2004). 606 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 607 devices in this family, counting this one, has a Class I recall.
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations between
- 3 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- 2 generations backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- 1 generation backK182239 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
- This deviceK252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2025
Show all 20 generations
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 8 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 7 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 6 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 5 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 4 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 3 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- 2 generations backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- 1 generation backK182239 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
- This deviceK252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2025
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −17 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −15 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −12 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −11 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −10 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −9 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −8 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −7 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −6 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −5 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −4 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| −3 | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corporation | 2015 | — |
| −2 | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | 1 |
| −1 | K182239 | OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC | 2018 | — |
| 0 (this device) | K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 8 | 0 |
| 1993 | 7 | 0 |
| 1994 | 10 | 0 |
| 1995 | 17 | 0 |
| 1996 | 14 | 0 |
| 1997 | 15 | 0 |
| 1998 | 21 | 0 |
| 1999 | 18 | 0 |
| 2000 | 34 | 0 |
| 2001 | 39 | 0 |
| 2002 | 32 | 0 |
| 2003 | 31 | 0 |
| 2004 | 37 | 0 |
| 2005 | 34 | 0 |
| 2006 | 30 | 0 |
| 2007 | 26 | 0 |
| 2008 | 32 | 0 |
| 2009 | 22 | 0 |
| 2010 | 30 | 1 |
| 2011 | 23 | 0 |
| 2012 | 16 | 0 |
| 2013 | 16 | 0 |
| 2014 | 9 | 0 |
| 2015 | 12 | 0 |
| 2016 | 11 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 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.
1 device in this family has a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K231694 | MASADA Modular Spinal Fixation SystemSummary page 7…21 CFR section 888.3070, 888.3050, 888.3010, 882.4560 Device Panel Orthopedic Primary Predicate Device MASADA Modular Spinal Fixation System (K231694) Additional Predicate OLYMPIC (K182239) Device(s) SI-Bone (K222774) Reunion (K2… | 2023 |
| * | K182239 | OLYMPIC Posterior Spinal Fixation SystemSummary page 7…, 888.3010, 882.4560 Device Panel Orthopedic Primary Predicate Device MASADA Modular Spinal Fixation System (K231694) Additional Predicate OLYMPIC (K182239) Device(s) SI-Bone (K222774) Reunion (K232211) Device Description The OLYMPIC… | 2018 |
| * | K222774 | iFuse Bedrock Granite® Implant SystemSummary page 7…Orthopedic Primary Predicate Device MASADA Modular Spinal Fixation System (K231694) Additional Predicate OLYMPIC (K182239) Device(s) SI-Bone (K222774) Reunion (K232211) Device Description The OLYMPIC Posterior Spinal Fixation System is a top lo… | 2022 |
| * | K232211 | REUNION Sacroiliac Joint Fusion SystemSummary page 7…DA Modular Spinal Fixation System (K231694) Additional Predicate OLYMPIC (K182239) Device(s) SI-Bone (K222774) Reunion (K232211) Device Description The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumba… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 8 companies; a new generation was cleared every 7 months on median.
- 67 of the 606 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K231694.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal…
Read the full statement (1,159 words)
Pedicle Screw System: The OLYMPIC Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Olympic Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Olympic Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Sublaminar Band System: The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
-Spinal trauma surgery, used in sublaminar or facet wiring techniques.
-Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis.
-Spinal degenerative surgery, as an adjunct to spinal fusions.
The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever “wiring” may help secure the attachment of the other implants.
S2Al Screws: The OLYMPIC Posterior Spinal Fixation System S2Al Screw System is intended for sacroiliac joint fusion for the following conditions:
« Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacrolliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
» To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
* Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
When connected to OLYMPIC posterior rods the OLYMPIC S2Al Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
* Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
» Spondylolisthesis
» Trauma (i.e., fracture or dislocation)
» Spinal stenosis
» Deformities or curvatures (i.e., scoliosis, kypohosis, and/or lordosis)
* Spinal tumor
* Pseudarthrosis
* Failed previous fusion
Navigated Instrument System: The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
Pedicle Screw System: The MASADA Modular Spinal Fixation System is intended for immmobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease ( defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MASADA pedicle screw implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MASADA pedicle screw is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Sublaminar Band System: The MASADA sublaminar band is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: - Spinal trauma surgery, used in sublaminar or facet wiring techniques. - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis. - Spinal degenerative surgery, as an adjunct to spinal fusions. The MASADA sublaminar band may also be used in conjunction with other medical grade implants made of similar metals whenever "wiring" may help secure the attachment of the other implants.
S2Al Screws: The MASADA Modular Spinal Fixation System S2Al Screw System is intended for sacroiliac joint fusion for the following conditions:
« Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
» To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
» Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
When connected to MASADA posterior rods the MASADA S2AIl Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to thoracolumbosacral fusion for the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
* Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
» Spondylolisthesis
* Trauma (i.e., fracture or dislocation)
* Spinal stenosis
» Deformities or curvatures (i.e., scoliosis, kypohosis, and/or lordosis)
* Spinal tumor
* Pseudarthrosis
* Failed previous fusion
Navigated Instrument System: The MASADA navigated instruments are intended to be used in the preparation and placement of MASADA screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252346 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252346: OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252346
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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