510(k) · Cleared
ClearedImse P-Tlif
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institute of Musculoskeletal Science & Education · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 13, 2013 as substantially equivalent to K121254 (Camber Spine Technologies, 2013) and 3 other predicates after a 75-day review. Its family tree reaches back 12 generations to 1984.
- Decided
- May 13, 2013
- Review
- 75 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K841189 (1984). 52 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 2 generations backK113138 Aleutian SystemK2m, Inc. · 2012
- 1 generation backK121254 Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies · 2013
- This deviceK130506 Imse P-TlifInstitute of Musculoskeletal Science & Education · 2013
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 4 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 3 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 2 generations backK113138 Aleutian SystemK2m, Inc. · 2012
- 1 generation backK121254 Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies · 2013
- This deviceK130506 Imse P-TlifInstitute of Musculoskeletal Science & Education · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −4 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −3 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −2 | K113138 | Aleutian System | K2m, Inc. | 2012 | — |
| −1 | K121254 | Camber Spine Technologies TLS 5.0 Inerbody Cage | Camber Spine Technologies | 2013 | — |
| 0 (this device) | K130506 | Imse P-Tlif | Institute of Musculoskeletal Science & Education | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K121254 | Camber Spine Technologies TLS 5.0 Inerbody Cage | 2013 |
| * | K073440 | Foundation CageSummary page 2…lassification Panel: Orthopedic Product Code MAX Reason for 510k New Device Predicate Devices Camber Cage (K1212S4), Corelink Foundation Cage (K 073440), Stryker AVS PL (K(093704) & K2M Aleutian (K(113138) Device Description Institute cf Musculoskeleta… | 2008 |
| * | K093704 | Avs PL Peek SpacersSummary page 2…MAX Reason for 510k New Device Predicate Devices Camber Cage (K1212S4), Corelink Foundation Cage (K 073440), Stryker AVS PL (K(093704) & K2M Aleutian (K(113138) Device Description Institute cf Musculoskeletal Science and Education, P-TLIF is a device… | 2009 |
| * | K113138 | Aleutian SystemSummary page 2…New Device Predicate Devices Camber Cage (K1212S4), Corelink Foundation Cage (K 073440), Stryker AVS PL (K(093704) & K2M Aleutian (K(113138) Device Description Institute cf Musculoskeletal Science and Education, P-TLIF is a device for inter… | 2012 |
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 29 years and passes through 10 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 52 ancestors have a recall of any class.
- 4 other devices also cite its predicate K121254.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Institute of Musculoskeletal Science & Education P-TUIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from 12-Si. DOD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved…
Read the full statement (127 words)
The Institute of Musculoskeletal Science & Education P-TUIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from 12-Si. DOD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Institute of Musculoskeletal Science & Education P-TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach.
Institute of Musculoskeletal Science & Education P-TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130506: Imse P-Tlif.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130506
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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