510(k) · Cleared
ClearedPASS LP™ Spinal System, CD Horizon™ Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicrea International SA · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 5, 2022 as substantially equivalent to K080099 (Medicrea Technologies, 2008) and 6 other predicates after a 96-day review. Its family tree reaches back 21 generations to 2004. 1 of the 475 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 5, 2022
- Review
- 96 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 21 generations to K040583 (2004). 474 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 475 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations between
- 3 generations backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- 2 generations backK182240 PASS LP Spinal SystemMedicrea International SA · 2018
- 1 generation backK190376 PASS LP Spinal SystemMedicrea International SA · 2019 · Recalled
- This deviceK213281 PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
Show all 21 generations
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 8 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 7 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 6 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 5 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 4 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
- 3 generations backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
- 2 generations backK182240 PASS LP Spinal SystemMedicrea International SA · 2018
- 1 generation backK190376 PASS LP Spinal SystemMedicrea International SA · 2019 · Recalled
- This deviceK213281 PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
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 |
|---|---|---|---|---|---|
| −21 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −18 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −17 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −16 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −14 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −13 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −12 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −11 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −10 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −9 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −8 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −7 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −6 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −5 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| −4 | K152632 | XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory | Stryker Corporation | 2015 | — |
| −3 | K170496 | Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory | Stryker Corporation | 2017 | 1 |
| −2 | K182240 | PASS LP Spinal System | Medicrea International SA | 2018 | — |
| −1 | K190376 | PASS LP Spinal System | Medicrea International SA | 2019 | 5 |
| 0 (this device) | K213281 | PASS LP™ Spinal System, CD Horizon™ Spinal System | Medicrea International SA | 2022 | — |
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 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 16 | 0 |
| 1996 | 11 | 0 |
| 1997 | 14 | 0 |
| 1998 | 21 | 0 |
| 1999 | 14 | 0 |
| 2000 | 30 | 0 |
| 2001 | 35 | 0 |
| 2002 | 27 | 0 |
| 2003 | 24 | 0 |
| 2004 | 30 | 0 |
| 2005 | 28 | 0 |
| 2006 | 27 | 0 |
| 2007 | 21 | 0 |
| 2008 | 27 | 0 |
| 2009 | 18 | 0 |
| 2010 | 25 | 1 |
| 2011 | 15 | 0 |
| 2012 | 9 | 0 |
| 2013 | 10 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 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.
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? (7)
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 |
|---|---|---|---|
| * | K080099 | Pass Spinal SystemSummary page 6…Class II 3. Predicate or legally marketed devices which are substantially equivalent: Primary predicate for PASS LP™ Spinal System: • PASS LP™ Spinal System (K080099, S.E. 09/04/2008) Primary predicate for CD Horizon™ Spinal System • CD Horizon™ Spinal System (K202771, S.E. 10/19/2021)… | 2008 |
| * | K202771 | CD Horizon Spinal SystemSummary page 6…te for PASS LP™ Spinal System: • PASS LP™ Spinal System (K080099, S.E. 09/04/2008) Primary predicate for CD Horizon™ Spinal System • CD Horizon™ Spinal System (K202771, S.E. 10/19/2021) Additional predicate device: • PASS LP™ Spinal System (K141398, S.E. 01/09/2015) • PASS LP™ Spinal Sy… | 2020 |
| * | K141398 | Pass LP Spinal SystemSummary page 6…Primary predicate for CD Horizon™ Spinal System • CD Horizon™ Spinal System (K202771, S.E. 10/19/2021) Additional predicate device: • PASS LP™ Spinal System (K141398, S.E. 01/09/2015) • PASS LP™ Spinal System (K190376, S.E. 05/02/2019) • PASS LP™ Spinal System (K140738, S.E. 11/04/2014)… | 2015 |
| * | K190376 | PASS LP Spinal SystemSummary page 6…CD Horizon™ Spinal System (K202771, S.E. 10/19/2021) Additional predicate device: • PASS LP™ Spinal System (K141398, S.E. 01/09/2015) • PASS LP™ Spinal System (K190376, S.E. 05/02/2019) • PASS LP™ Spinal System (K140738, S.E. 11/04/2014) • CD Horizon™ Spinal System (K150178, S.E. 02/11/2015… | 2019 |
| * | K140738 | Pass LP Spinal SystemSummary page 6…Additional predicate device: • PASS LP™ Spinal System (K141398, S.E. 01/09/2015) • PASS LP™ Spinal System (K190376, S.E. 05/02/2019) • PASS LP™ Spinal System (K140738, S.E. 11/04/2014) • CD Horizon™ Spinal System (K150178, S.E. 02/11/2015) • CD Horizon™ Spinal System (K132471, S.E. 10/08/2… | 2014 |
| * | K150178 | CD Horizon Spinal SystemSummary page 6…(K141398, S.E. 01/09/2015) • PASS LP™ Spinal System (K190376, S.E. 05/02/2019) • PASS LP™ Spinal System (K140738, S.E. 11/04/2014) • CD Horizon™ Spinal System (K150178, S.E. 02/11/2015) • CD Horizon™ Spinal System (K132471, S.E. 10/08/2013) The predicates have not been subject to a design… | 2015 |
| * | K132471 | CD Horizon Spinal SystemSummary page 6…190376, S.E. 05/02/2019) • PASS LP™ Spinal System (K140738, S.E. 11/04/2014) • CD Horizon™ Spinal System (K150178, S.E. 02/11/2015) • CD Horizon™ Spinal System (K132471, S.E. 10/08/2013) The predicates have not been subject to a design related recall. 4. Description of the device: === Page 7… | 2013 |
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 18 years and passes through 7 companies; a new generation was cleared every 6 months on median.
- 49 of the 474 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K080099.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)…
Read the full statement (586 words)
The PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (e.g., fracture or dislocation), deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.
Except for rod plates and caps for sacral plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP™ Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.
With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213281: PASS LP™ Spinal System, CD Horizon™ Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213281
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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