510(k) · Cleared
ClearedA8 INTEGR8™ Porous Pedicle Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allumin8, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Oct 20, 2025 as substantially equivalent to K200303 (Precision Spine, 2020) and 2 other predicates after a 397-day review. Its family tree reaches back 20 generations to 2004. 1 of the 537 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Oct 20, 2025
- Review
- 397 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K040583 (2004). 535 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 537 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 backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 2 generations backK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
- 1 generation backK190360 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2019
- This deviceK242827 A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK262067 iFuse Granite Onyx™ Implant SystemSI-BONE, Inc. · 2026
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 backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 5 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 4 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 3 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 2 generations backK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
- 1 generation backK190360 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2019
- This deviceK242827 A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc. · 2025
Class I recalls in this family
- K100952 Modification to Synthes Matrix System5 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc. · 2026 · cites it directly0descendants
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 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −5 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −4 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −3 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| −2 | K170126 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K190360 | LineSider™ Spinal System | Integrity Implants, Inc. | 2019 | — |
| 0 (this device) | K242827 | A8 INTEGR8™ Porous Pedicle Screws | Allumin8, Inc. | 2025 | — |
| +1 | K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | 2026 | — |
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 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 17 | 0 |
| 1996 | 13 | 0 |
| 1997 | 14 | 0 |
| 1998 | 23 | 0 |
| 1999 | 18 | 0 |
| 2000 | 29 | 0 |
| 2001 | 37 | 0 |
| 2002 | 31 | 0 |
| 2003 | 31 | 0 |
| 2004 | 47 | 0 |
| 2005 | 37 | 0 |
| 2006 | 32 | 0 |
| 2007 | 22 | 0 |
| 2008 | 31 | 0 |
| 2009 | 24 | 0 |
| 2010 | 21 | 1 |
| 2011 | 19 | 0 |
| 2012 | 9 | 0 |
| 2013 | 9 | 0 |
| 2014 | 10 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K200303 | Reform Pedicle Screw SystemSummary page 6…and Sizes Predicate Devices 510k # Trade or Proprietary or Model Name Manufacturer Product Code Predicate Type K200303 Reform Pedicle Screw System Precision Spine, Inc. NKB, KWP Primary K202498… | 2020 |
| * | K202498 | 4CIS SARA Spine System, 4CIS VERTU Spine SystemSummary page 6…Product Code Predicate Type K200303 Reform Pedicle Screw System Precision Spine, Inc. NKB, KWP Primary K202498 4CIS SARA Spine System, 4CIS VERTU Spine System Solco Biomedical Company India Private Limited NKB Additional K19036… | 2021 |
| * | K190360 | LineSider™ Spinal SystemSummary page 6…NKB, KWP Primary K202498 4CIS SARA Spine System, 4CIS VERTU Spine System Solco Biomedical Company India Private Limited NKB Additional K190360 LineSider Spinal System Integrity Implants Inc. NKB, KWP Additional… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262067 | iFuse Granite Onyx™ Implant System | 2026 | 0 |
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 · 5 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 7 companies; a new generation was cleared every 7 months on median.
- 58 of the 535 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K262067 (SI-BONE, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K200303.
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?
ALLUMIN8® A8 INTEGR8™ porous pedicle screws are intended to immobilize and stabilize spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system to treat the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: 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 (187 words)
ALLUMIN8® A8 INTEGR8™ porous pedicle screws are intended to immobilize and stabilize spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system to treat the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:
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. Spinal Tumor;
7. Pseudoarthrosis; and
8. Failed previous fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the 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 ALLUMIN8® A8 INTEGR8™ porous pedicle screws are intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudoarthrosis, and/or failed previous fusion. Pediatric pedicle screw fixation is limited to a posterior approach.
ALLUMIN8® A8 INTEGR8™ Porous Pedicle Screws are intended to be used with autograft or allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242827: A8 INTEGR8™ Porous Pedicle Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242827
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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