510(k) · Cleared
ClearedSierra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Apr 17, 2008 as substantially equivalent to K062934 (Seaspine, Inc., 2006) and 3 other predicates after a 204-day review. Its family tree reaches back 10 generations to 1985. 5 later devices descend from it.
- Decided
- Apr 17, 2008
- Review
- 204 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K853033 (1985). 34 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062934 SierraSeaspine, Inc. · 2006
- This deviceK072729 SierraSeaspine, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK112025 Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA · 2011
- Descendant · 2 generations on · 3 of its ownK150851 Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK162300 Reform® POCT SystemPrecision Spine, Inc. · 2016
- Descendant · 4 generations on · 1 of its ownK172495 Reform® POCT SystemPrecision Spine, Inc. · 2018
- Descendant · 5 generations on · 0 of its ownK222107 Black Diamond™ POCT Spinal SystemOsseus Fusion Systems · 2022
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK042508 Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc. · 2004
- 1 generation backK062934 SierraSeaspine, Inc. · 2006
- This deviceK072729 SierraSeaspine, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K112025Sure Lok Mini Posterior Cervical/Upper Thoracic SystemSpinal USA · 2011 · cites it directly4descendants
- K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015 · 2 generations on3descendants
- K162300Reform® POCT SystemPrecision Spine, Inc. · 2016 · 3 generations on2descendants
- K172495Reform® POCT SystemPrecision Spine, Inc. · 2018 · 4 generations on1descendant
- K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems · 2022 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K042508 | Sumit Oct Spinal System and Mountaineer Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −1 | K062934 | Sierra | Seaspine, Inc. | 2006 | — |
| 0 (this device) | K072729 | Sierra | Seaspine, Inc. | 2008 | — |
| +1 | K112025 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Spinal USA | 2011 | — |
| +2 | K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Precision Spine, Inc. | 2015 | — |
| +3 | K162300 | Reform® POCT System | Precision Spine, Inc. | 2016 | — |
| +4 | K172495 | Reform® POCT System | Precision Spine, Inc. | 2018 | — |
| +5 | K222107 | Black Diamond™ POCT Spinal System | Osseus Fusion Systems | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K062934 | SierraSummary page 1…KWP (Class II) - 888.3050 Substantial equivalence claimed to: The devices used for comparison in this summary are SeaSpine, Inc.'s Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229). The overall designs of the rod conn… | 2006 |
| * | K022048 | Interpore Cross International (Ici) Occipito-Cervico-Thoracic (Oct) Rod and Plate SystemSummary page 1…med to: The devices used for comparison in this summary are SeaSpine, Inc.'s Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229). The overall designs of the rod connectors, crossbars and set screws in this submission are subst… | 2002 |
| * | K033961 | Altius Oct SystemSummary page 1…The devices used for comparison in this summary are SeaSpine, Inc.'s Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229). The overall designs of the rod connectors, crossbars and set screws in this submission are substantially… | 2004 |
| * | K043229 | Modification to Altius Oct SystemSummary page 1…used for comparison in this summary are SeaSpine, Inc.'s Sierra Spinal System (K062934) and Interpore Cross International's Altius OCT System (K022048, K033961 and K043229). The overall designs of the rod connectors, crossbars and set screws in this submission are substantially equivalent to t… | 2004 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112025 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | 2011 | 4 |
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 23 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 34 ancestors has a recall of any class.
- Of its descendants, K112025 (Spinal USA, 2011) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K062934.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows: * degenerative disc disease (DDD) as defined by neck 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, * atlantoaxial fracture with…
Read the full statement (124 words)
The intended use of the Sierra spinal system is to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). The indications for use are as follows:
* degenerative disc disease (DDD) as defined by neck 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,
* atlantoaxial fracture with instability,
* occipitocervical dislocation,
* revision of previous cervical spine surgery, and/or
* spinal tumor.
The occipital bone screws are limited to occipital fixation only.
The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072729 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072729: Sierra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072729
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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